Vail OCT Spinal Fixation System
483 catalogue numbers from 7908-3532, listed by Biomet Spine, United States, under Appliance, Fixation, Spinal Interlaminal. 11 manufacturers in China are registered for this product code.
11manufacturers in China registered for this device type
483catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Jiangsu (5), Shandong (2), Shanghai (1). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| APS Materials Suzhou | Suzhou | Jiangsu | Contract manufacturer | 18 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
| Double Medical Technology Inc. | Xiamen | Fujian | Contract manufacturer | 14 |
| Zhejiang Decans Medical Devices Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 10 |
Record
| Listed by | Biomet Spine, United States |
|---|---|
| FDA product code | KWP |
| Device type | Appliance, Fixation, Spinal Interlaminal |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3050 |
| Record published | 2015-10-24 |
| Record revised | 2025-07-02 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 7908-3532 | SCREW ASSY POLY Ø4.0 ROD Ø3.5X32MM | In distribution |
| 7907-0025 | D-ROD STRAIGHT TI Ø3.0X2.0X25MM | In distribution |
| 7907-3128 | CROSSBAND HEAD TO HEAD TI 28MM | In distribution |
| 7918-3532 | POLY SCREW SM SHK TI 4.0 ROD Ø3.5X32MM | In distribution |
| 7915-3517 | SCREW ASSY TURRET TI Ø3.5X17MM | In distribution |
| 7906-4514 | SCREW OCCIPITAL TI Ø4.5X14MM | In distribution |
| 7908-3546 | SCREW ASSY POLY Ø4.0 ROD Ø3.5X46MM | In distribution |
| 7909-1065 | ROD PREBENT TI Ø4.0X65MM | In distribution |
| 7901-6075 | ROD PREBENT COCR R170 Ø3.5X75MM | In distribution |
| 7902-4533 | PEDICLE SCREW TI Ø4.5X33MM | In distribution |
| 7918-4034 | POLY SCREW SM SHK TI 4.0 ROD Ø4.0X34MM | In distribution |
| 7908-4010 | SCREW ASSY POLY Ø4.0 ROD Ø4.0X10MM | In distribution |
| 7907-0070 | D-ROD STRAIGHT TI Ø3.0X2.0X70MM | In distribution |
| 7918-3527 | POLY SCREW SM SHK TI 4.0 ROD Ø3.5X27MM | In distribution |
| 7909-1075 | ROD PREBENT TI Ø4.0X75MM | In distribution |
| 7902-3542 | PEDICLE SCREW TI Ø3.5X42MM | In distribution |
| 7908-3510 | SCREW ASSY POLY Ø4.0 ROD Ø3.5X10MM | In distribution |
| 7909-0190 | ROD STRAIGHT TI Ø4.0X190MM | In distribution |
| 7902-4516 | PEDICLE SCREW TI Ø4.5X16MM | In distribution |
| 7909-5085 | ROD STRAIGHT COCR Ø4.0X85MM | In distribution |
| 7915-3534 | SCREW ASSY TURRET TI Ø3.5X34MM | In distribution |
| 7902-4037 | PEDICLE SCREW TI Ø4.0X37MM | In distribution |
| 7915-4518 | SCREW ASSY TURRET TI Ø4.5X18MM | In distribution |
| 7902-4520 | PEDICLE SCREW TI Ø4.5X20MM | In distribution |
| 7909-0070 | ROD STRAIGHT TI Ø4.0X70MM | In distribution |
| 7909-0130 | ROD STRAIGHT TI Ø4.0X130MM | In distribution |
| 7918-4039 | POLY SCREW SM SHK TI 4.0 ROD Ø4.0X39MM | In distribution |
| 7909-5180 | ROD STRAIGHT COCR Ø4.0X180MM | In distribution |
| 7901-5060 | ROD STRAIGHT COCR Ø3.5X60MM | In distribution |
| 7909-0250 | ROD STRAIGHT TI Ø4.0X250MM | In distribution |
| 7715-4025 | Pedicle Screw Ti Ø4.0x25mm | In distribution |
| 7918-3530 | POLY SCREW SM SHK TI 4.0 ROD Ø3.5X30MM | In distribution |
| 7909-1125 | ROD PREBENT TI Ø4.0X125MM | In distribution |
| 7918-3544 | POLY SCREW SM SHK TI 4.0 ROD Ø3.5X44MM | In distribution |
| 7909-5045 | ROD STRAIGHT COCR Ø4.0X45MM | In distribution |
| 7902-4030 | PEDICLE SCREW TI Ø4.0X30MM | In distribution |
| 7916-4033 | SCREW ASSY TURRET SMTH SHNK TI Ø4.0X33MM | In distribution |
| 7909-1020 | ROD PREBENT TI Ø4.0X20MM | In distribution |
| 7902-4535 | PEDICLE SCREW TI Ø4.5X35MM | In distribution |
| 7909-0045 | ROD STRAIGHT TI Ø4.0X45MM | In distribution |
| 7918-3536 | POLY SCREW SM SHK TI 4.0 ROD Ø3.5X36MM | In distribution |
| 7915-4041 | SCREW ASSY TURRET TI Ø4.0X41MM | In distribution |
| 7715-4025 | PEDICLE SCREW TI Ø4.0X25MM | In distribution |
| 7909-5115 | ROD STRAIGHT COCR Ø4.0X115MM | In distribution |
| 7911-3537 | PEDICLE SCREW SMOOTH SHANK TI Ø3.5X37MM | In distribution |
| 7715-4045 | Pedicle Screw Ti Ø4.0x45mm | In distribution |
| 7918-3525 | POLY SCREW SM SHK TI 4.0 ROD Ø3.5X25MM | In distribution |
| 7918-3528 | POLY SCREW SM SHK TI 4.0 ROD Ø3.5X28MM | In distribution |
| 7909-5100 | ROD STRAIGHT COCR Ø4.0X100MM | In distribution |
| 7909-6055 | ROD PREBENT COCR Ø4.0X55MM | In distribution |
| 7909-5150 | ROD STRAIGHT COCR Ø4.0X150MM | In distribution |
| 7915-4527 | SCREW ASSY TURRET TI Ø4.5X27MM | In distribution |
| 7909-5035 | ROD STRAIGHT COCR Ø4.0X35MM | In distribution |
| 7908-3516 | SCREW ASSY POLY Ø4.0 ROD Ø3.5X16MM | In distribution |
| 7909-5200 | ROD STRAIGHT COCR Ø4.0X200MM | In distribution |
| 7901-5100 | ROD STRAIGHT COCR Ø3.5X100MM | In distribution |
| 7907-0030 | D-ROD STRAIGHT TI Ø3.0X2.0X30MM | In distribution |
| 7908-3534 | SCREW ASSY POLY Ø4.0 ROD Ø3.5X34MM | In distribution |
| 7901-5125 | ROD STRAIGHT COCR Ø3.5X125MM | In distribution |
| 7908-3520 | SCREW ASSY POLY Ø4.0 ROD Ø3.5X20MM | In distribution |
| 7909-2225 | OCT ROD PREBENT TI Ø4.0X75X225MM | In distribution |
| 7909-5225 | ROD STRAIGHT COCR Ø4.0X225MM | In distribution |
| 7918-4035 | POLY SCREW SM SHK TI 4.0 ROD Ø4.0X35MM | In distribution |
| 7918-3529 | POLY SCREW SM SHK TI 4.0 ROD Ø3.5X29MM | In distribution |
| 7901-5080 | ROD STRAIGHT COCR Ø3.5X80MM | In distribution |
| 7902-4546 | PEDICLE SCREW TI Ø4.5X46MM | In distribution |
| 7901-6065 | ROD PREBENT COCR R170 Ø3.5X65MM | In distribution |
| 7918-4027 | POLY SCREW SM SHK TI 4.0 ROD Ø4.0X27MM | In distribution |
| 7715-4015 | Pedicle Screw Ti Ø4.0x15mm | In distribution |
| 7915-3526 | SCREW ASSY TURRET TI Ø3.5X26MM | In distribution |
| 7905-4245 | T-PLATE OCCIPITAL FIXED TI 45MM | In distribution |
| 7902-4022 | PEDICLE SCREW TI Ø4.0X22MM | In distribution |
| 7909-1080 | ROD PREBENT TI Ø4.0X80MM | In distribution |
| 7915-4031 | SCREW ASSY TURRET TI Ø4.0X31MM | In distribution |
| 7918-3543 | POLY SCREW SM SHK TI 4.0 ROD Ø3.5X43MM | In distribution |
| 7902-4545 | PEDICLE SCREW TI Ø4.5X45MM | In distribution |
| 7915-4522 | SCREW ASSY TURRET TI Ø4.5X22MM | In distribution |
| 7715-4030 | Pedicle Screw Ti Ø4.0x30mm | In distribution |
| 7901-6030 | ROD PREBENT COCR R170 Ø3.5X30MM | In distribution |
| 7909-0300 | ROD STRAIGHT TI Ø4.0X300MM | In distribution |
| 7909-0080 | ROD STRAIGHT TI Ø4.0X80MM | In distribution |
| 7906-4511 | SCREW OCCIPITAL TI Ø4.5X11MM | In distribution |
| 7909-6035 | ROD PREBENT COCR Ø4.0X35MM | In distribution |
| 7909-1060 | ROD PREBENT TI Ø4.0X60MM | In distribution |
| 7906-5306 | SCREW OCCIPITAL TI Ø5.3X6MM | In distribution |
| 7908-4043 | SCREW ASSY POLY Ø4.0 ROD Ø4.0X43MM | In distribution |
| 7902-4528 | PEDICLE SCREW TI Ø4.5X28MM | In distribution |
| 7909-5075 | ROD STRAIGHT COCR Ø4.0X75MM | In distribution |
| 7902-4531 | PEDICLE SCREW TI Ø4.5X31MM | In distribution |
| 7918-4026 | POLY SCREW SM SHK TI 4.0 ROD Ø4.0X26MM | In distribution |
| 7909-5055 | ROD STRAIGHT COCR Ø4.0X55MM | In distribution |
| 7902-4041 | PEDICLE SCREW TI Ø4.0X41MM | In distribution |
| 7901-6095 | ROD PREBENT COCR R170 Ø3.5X95MM | In distribution |
| 7909-1035 | ROD PREBENT TI Ø4.0X35MM | In distribution |
| 7901-6085 | ROD PREBENT COCR R170 Ø3.5X85MM | In distribution |
| 7918-4029 | POLY SCREW SM SHK TI 4.0 ROD Ø4.0X29MM | In distribution |
| 7901-6130 | ROD PREBENT COCR R170 Ø3.5X130MM | In distribution |
| 7909-6170 | ROD PREBENT COCR Ø4.0X170MM | In distribution |
| 7908-4011 | SCREW ASSY POLY Ø4.0 ROD Ø4.0X11MM | In distribution |
| 7902-4529 | PEDICLE SCREW TI Ø4.5X29MM | In distribution |
| 7902-4042 | PEDICLE SCREW TI Ø4.0X42MM | In distribution |
| 7909-0095 | ROD STRAIGHT TI Ø4.0X95MM | In distribution |
| 7918-4031 | POLY SCREW SM SHK TI 4.0 ROD Ø4.0X31MM | In distribution |
| 7909-6040 | ROD PREBENT COCR Ø4.0X40MM | In distribution |
| 7906-5315 | SCREW OCCIPITAL TI Ø5.3X15MM | In distribution |
| 7909-6060 | ROD PREBENT COCR Ø4.0X60MM | In distribution |
| 7915-3546 | SCREW ASSY TURRET TI Ø3.5X46MM | In distribution |
| 7909-0030 | ROD STRAIGHT TI Ø4.0X30MM | In distribution |
| 7908-4047 | SCREW ASSY POLY Ø4.0 ROD Ø4.0X47MM | In distribution |
| 7908-3513 | SCREW ASSY POLY Ø4.0 ROD Ø3.5X13MM | In distribution |
| 7901-5160 | ROD STRAIGHT COCR Ø3.5X160MM | In distribution |
| 7902-4514 | PEDICLE SCREW TI Ø4.5X14MM | In distribution |
| 7909-0065 | ROD STRAIGHT TI Ø4.0X65MM | In distribution |
| 7908-3538 | SCREW ASSY POLY Ø4.0 ROD Ø3.5X38MM | In distribution |
| 7909-1055 | ROD PREBENT TI Ø4.0X55MM | In distribution |
| 7908-4032 | SCREW ASSY POLY Ø4.0 ROD Ø4.0X32MM | In distribution |
| 7918-4044 | POLY SCREW SM SHK TI 4.0 ROD Ø4.0X44MM | In distribution |
| 7901-3125 | ROD PREBENT OCCIPITAL TI Ø3.5X75X125MM | In distribution |
| 7901-6110 | ROD PREBENT COCR R170 Ø3.5X110MM | In distribution |
| 7918-3531 | POLY SCREW SM SHK TI 4.0 ROD Ø3.5X31MM | In distribution |
| 7915-4010 | SCREW ASSY TURRET TI Ø4.0X10MM | In distribution |
| 7908-4022 | SCREW ASSY POLY Ø4.0 ROD Ø4.0X22MM | In distribution |
| 7901-4125 | ROD PREBENT OCCIPITAL TI Ø4.0X75X125MM | In distribution |
| 7902-3539 | PEDICLE SCREW TI Ø3.5X39MM | In distribution |
| 7902-4027 | PEDICLE SCREW TI Ø4.0X27MM | In distribution |
| 7902-4510 | PEDICLE SCREW TI Ø4.5X10MM | In distribution |
| 7715-4040 | PEDICLE SCREW TI Ø4.0X40MM | In distribution |
| 7901-5040 | ROD STRAIGHT COCR Ø3.5X40MM | In distribution |
| 7902-3535 | PEDICLE SCREW TI Ø3.5X35MM | In distribution |
| 7901-5300 | ROD STRAIGHT COCR Ø3.5X300MM | In distribution |
| 7902-4538 | PEDICLE SCREW TI Ø4.5X38MM | In distribution |
| 7908-3530 | SCREW ASSY POLY Ø4.0 ROD Ø3.5X30MM | In distribution |
| 7909-0020 | ROD STRAIGHT TI Ø4.0X20MM | In distribution |
| 7901-5025 | ROD STRAIGHT COCR Ø3.5X25MM | In distribution |
| 7902-4513 | PEDICLE SCREW TI Ø4.5X13MM | In distribution |
| 7909-6140 | ROD PREBENT COCR Ø4.0X140MM | In distribution |
| 7902-4544 | PEDICLE SCREW TI Ø4.5X44MM | In distribution |
| 7901-5020 | ROD STRAIGHT COCR Ø3.5X20MM | In distribution |
| 7908-4025 | SCREW ASSY POLY Ø4.0 ROD Ø4.0X25MM | In distribution |
| 7915-3548 | SCREW ASSY TURRET TI Ø3.5X48MM | In distribution |
| 7918-3537 | POLY SCREW SM SHK TI 4.0 ROD Ø3.5X37MM | In distribution |
| 7909-5110 | ROD STRAIGHT COCR Ø4.0X110MM | In distribution |
| 7901-3401 | ROD TRANSIT STRT TI Ø3.5XØ5.5X400MM | In distribution |
| 7902-4519 | PEDICLE SCREW TI Ø4.5X19MM | In distribution |
| 7918-3524 | POLY SCREW SM SHK TI 4.0 ROD Ø3.5X24MM | In distribution |
| 7918-4024 | POLY SCREW SM SHK TI 4.0 ROD Ø4.0X24MM | In distribution |
| 7909-1200 | ROD PREBENT TI Ø4.0X200MM | In distribution |
| 7901-9125 | ROD PREBENT OCCIPITAL COCR Ø4.0X75X125MM | In distribution |
| 7903-4060 | HOOK IN-LINE TI Ø4.0MM ROD 6.0MM | In distribution |
| 7915-3521 | SCREW ASSY TURRET TI Ø3.5X21MM | In distribution |
| 7907-0055 | D-ROD STRAIGHT TI Ø3.0X2.0X55MM | In distribution |
| 7909-5080 | ROD STRAIGHT COCR Ø4.0X80MM | In distribution |
| 7902-4021 | PEDICLE SCREW TI Ø4.0X21MM | In distribution |
| 7909-1110 | ROD PREBENT TI Ø4.0X110MM | In distribution |
| 7908-4038 | SCREW ASSY POLY Ø4.0 ROD Ø4.0X38MM | In distribution |
| 7908-4035 | SCREW ASSY POLY Ø4.0 ROD Ø4.0X35MM | In distribution |
| 7908-3545 | SCREW ASSY POLY Ø4.0 ROD Ø3.5X45MM | In distribution |
| 7908-4039 | SCREW ASSY POLY Ø4.0 ROD Ø4.0X39MM | In distribution |
| 7908-3521 | SCREW ASSY POLY Ø4.0 ROD Ø3.5X21MM | In distribution |
| 7902-4548 | PEDICLE SCREW TI Ø4.5X48MM | In distribution |
| 7909-1160 | ROD PREBENT TI Ø4.0X160MM | In distribution |
| 7715-4045 | PEDICLE SCREW TI Ø4.0X45MM | In distribution |
| 7909-6180 | ROD PREBENT COCR Ø4.0X180MM | In distribution |
| 7901-6170 | ROD PREBENT COCR R170 Ø3.5X170MM | In distribution |
| 7909-0085 | ROD STRAIGHT TI Ø4.0X85MM | In distribution |
| 7909-1150 | ROD PREBENT TI Ø4.0X150MM | In distribution |
| 7909-0125 | ROD STRAIGHT TI Ø4.0X125MM | In distribution |
| 7909-6120 | ROD PREBENT COCR Ø4.0X120MM | In distribution |
| 7901-6040 | ROD PREBENT COCR R170 Ø3.5X40MM | In distribution |
| 7901-5095 | ROD STRAIGHT COCR Ø3.5X95MM | In distribution |
| 7715-4015 | PEDICLE SCREW TI Ø4.0X15MM | In distribution |
| 7909-5160 | ROD STRAIGHT COCR Ø4.0X160MM | In distribution |
| 7918-4040 | POLY SCREW SM SHK TI 4.0 ROD Ø4.0X40MM | In distribution |
| 7901-5090 | ROD STRAIGHT COCR Ø3.5X90MM | In distribution |
| 7901-6115 | ROD PREBENT COCR R170 Ø3.5X115MM | In distribution |
| 7909-6080 | ROD PREBENT COCR Ø4.0X80MM | In distribution |
| 7901-6200 | ROD PREBENT COCR R170 Ø3.5X200MM | In distribution |
| 7909-1100 | ROD PREBENT TI Ø4.0X100MM | In distribution |
| 7901-6160 | ROD PREBENT COCR R170 Ø3.5X160MM | In distribution |
| 7906-4517 | SCREW OCCIPITAL TI Ø4.5X17MM | In distribution |
| 7908-4031 | SCREW ASSY POLY Ø4.0 ROD Ø4.0X31MM | In distribution |
| 7909-5125 | ROD STRAIGHT COCR Ø4.0X125MM | In distribution |
| 7916-3533 | SCREW ASSY TURRET SMTH SHNK TI Ø3.5X33MM | In distribution |
| 7918-3539 | POLY SCREW SM SHK TI 4.0 ROD Ø3.5X39MM | In distribution |
| 7909-6110 | ROD PREBENT COCR Ø4.0X110MM | In distribution |
| 7909-1045 | ROD PREBENT TI Ø4.0X45MM | In distribution |
| 7909-1105 | ROD PREBENT TI Ø4.0X105MM | In distribution |
| 7918-3538 | POLY SCREW SM SHK TI 4.0 ROD Ø3.5X38MM | In distribution |
| 7908-4017 | SCREW ASSY POLY Ø4.0 ROD Ø4.0X17MM | In distribution |
| 7902-3526 | PEDICLE SCREW TI Ø3.5X26MM | In distribution |
| 7901-6140 | ROD PREBENT COCR R170 Ø3.5X140MM | In distribution |
| 7909-1085 | ROD PREBENT TI Ø4.0X85MM | In distribution |
| 7916-4035 | SCREW ASSY TURRET SMTH SHNK TI Ø4.0X35MM | In distribution |
| 7902-4541 | PEDICLE SCREW TI Ø4.5X41MM | In distribution |
| 7715-4035 | PEDICLE SCREW TI Ø4.0X35MM | In distribution |
| 7902-4539 | PEDICLE SCREW TI Ø4.5X39MM | In distribution |
| 7908-4044 | SCREW ASSY POLY Ø4.0 ROD Ø4.0X44MM | In distribution |
| 7909-0160 | ROD STRAIGHT TI Ø4.0X160MM | In distribution |
| 7918-3533 | POLY SCREW SM SHK TI 4.0 ROD Ø3.5X33MM | In distribution |
| 7918-4028 | POLY SCREW SM SHK TI 4.0 ROD Ø4.0X28MM | In distribution |
| 7907-0080 | D-ROD STRAIGHT TI Ø3.0X2.0X80MM | In distribution |
| 7909-6125 | ROD PREBENT COCR Ø4.0X125MM | In distribution |
| 7908-4024 | SCREW ASSY POLY Ø4.0 ROD Ø4.0X24MM | In distribution |
| 7909-5025 | ROD STRAIGHT COCR Ø4.0X25MM | In distribution |
| 7901-6190 | ROD PREBENT COCR R170 Ø3.5X190MM | In distribution |
| 7908-3540 | SCREW ASSY POLY Ø4.0 ROD Ø3.5X40MM | In distribution |
| 7918-4032 | POLY SCREW SM SHK TI 4.0 ROD Ø4.0X32MM | In distribution |
| 7902-4035 | PEDICLE SCREW TI Ø4.0X35MM | In distribution |
| 7908-3542 | SCREW ASSY POLY Ø4.0 ROD Ø3.5X42MM | In distribution |
| 7915-4048 | SCREW ASSY TURRET TI Ø4.0X48MM | In distribution |
| 7915-3542 | SCREW ASSY TURRET TI Ø3.5X42MM | In distribution |
| 7909-5020 | ROD STRAIGHT COCR Ø4.0X20MM | In distribution |
| 7901-8125 | ROD PREBENT OCCIPITAL COCR Ø3.5X75X125MM | In distribution |
| 7908-3528 | SCREW ASSY POLY Ø4.0 ROD Ø3.5X28MM | In distribution |
| 7918-4037 | POLY SCREW SM SHK TI 4.0 ROD Ø4.0X37MM | In distribution |
| 7909-6160 | ROD PREBENT COCR Ø4.0X160MM | In distribution |
| 7909-6045 | ROD PREBENT COCR Ø4.0X45MM | In distribution |
| 7915-4543 | SCREW ASSY TURRET TI Ø4.5X43MM | In distribution |
| 7908-3511 | SCREW ASSY POLY Ø4.0 ROD Ø3.5X11MM | In distribution |
| 7918-4042 | POLY SCREW SM SHK TI 4.0 ROD Ø4.0X42MM | In distribution |
| 7909-5170 | ROD STRAIGHT COCR Ø4.0X170MM | In distribution |
| 7901-6020 | ROD PREBENT COCR R170 Ø3.5X20MM | In distribution |
| 7902-4542 | PEDICLE SCREW TI Ø4.5X42MM | In distribution |
| 7909-5300 | ROD STRAIGHT COCR Ø4.0X300MM | In distribution |
| 7901-8225 | ROD PREBENT OCCIPITAL COCR Ø3.5X75X225MM | In distribution |
| 7902-4517 | PEDICLE SCREW TI Ø4.5X17MM | In distribution |
| 7908-3523 | SCREW ASSY POLY Ø4.0 ROD Ø3.5X23MM | In distribution |
| 7902-4023 | PEDICLE SCREW TI Ø4.0X23MM | In distribution |
| 7911-3533 | PEDICLE SCREW SMOOTH SHANK TI Ø3.5X33MM | In distribution |
| 7902-4511 | PEDICLE SCREW TI Ø4.5X11MM | In distribution |
| 7908-4034 | SCREW ASSY POLY Ø4.0 ROD Ø4.0X34MM | In distribution |
| 7902-4524 | PEDICLE SCREW TI Ø4.5X24MM | In distribution |
| 7908-4021 | SCREW ASSY POLY Ø4.0 ROD Ø4.0X21MM | In distribution |
| 7902-4543 | PEDICLE SCREW TI Ø4.5X43MM | In distribution |
| 7901-5085 | ROD STRAIGHT COCR Ø3.5X85MM | In distribution |
| 7901-5045 | ROD STRAIGHT COCR Ø3.5X45MM | In distribution |
| 7902-4547 | PEDICLE SCREW TI Ø4.5X47MM | In distribution |
| 7909-6085 | ROD PREBENT COCR Ø4.0X85MM | In distribution |
| 7908-3529 | SCREW ASSY POLY Ø4.0 ROD Ø3.5X29MM | In distribution |
| 7902-3546 | PEDICLE SCREW TI Ø3.5X46MM | In distribution |
| 7908-3544 | SCREW ASSY POLY Ø4.0 ROD Ø3.5X44MM | In distribution |
| 7901-5190 | ROD STRAIGHT COCR Ø3.5X190MM | In distribution |
| 7901-6055 | ROD PREBENT COCR R170 Ø3.5X55MM | In distribution |
| 7906-5318 | SCREW OCCIPITAL TI Ø5.3X18MM | In distribution |
| 7909-0060 | ROD STRAIGHT TI Ø4.0X60MM | In distribution |
| 7909-0225 | ROD STRAIGHT TI Ø4.0X225MM | In distribution |
| 7901-5240 | ROD STRAIGHT COCR Ø3.5X240MM | In distribution |
| 7909-6030 | ROD PREBENT COCR Ø4.0X30MM | In distribution |
| 7918-4041 | POLY SCREW SM SHK TI 4.0 ROD Ø4.0X41MM | In distribution |
| 7906-5310 | SCREW OCCIPITAL TI Ø5.3X10MM | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Invictus | Alphatec Spine, Inc. | 5,422 |
| ReLine | Nuvasive, Inc. | 4,439 |
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 3,188 |
| Creo | Globus Medical, Inc. | 1,992 |
| Apex Spine System | Spinecraft LLC | 1,319 |
| LnK Spinal Fixation System | L&K Biomed Co., Ltd. | 1,271 |
| Perla ® TL | Spineart SA | 1,035 |
| Astra Spine System | Spinecraft LLC | 1,003 |
| LineSider | Highridge Medical, LLC | 948 |
| Apex-DL Spine System | Spinecraft LLC | 909 |
| Revere | Globus Medical, Inc. | 875 |
| AccelFix Spinal Fixation System | L&K Biomed Co., Ltd. | 841 |
Showing 12 of 536. All products under Appliance, Fixation, Spinal Interlaminal
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K071377 | 2007-08-06 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.