Alta Acdf System
Screw Self-Drill Variable Ti ø3.5x16mm
5manufacturers in China registered for this device type
127catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (2), Guangdong (1), Jiangsu (1). 3 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 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Zhisu Health Tech Jiaxing Co., Ltd. | Tongxiang | Zhejiang | Contract manufacturer | 4 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Zhejiang Decans Medical Devices Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 10 |
Record
| Listed by | Highridge Medical, LLC, United States |
|---|---|
| FDA product code | OVE |
| Device type | Intervertebral Fusion Device With Integrated Fixation, Cervical |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| Establishment | Specification developer, Manufacturer |
| Record published | 2025-12-18 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 8409-2109 | Device Size Text, specify—Half-Plate Caudal Ti 9mm | In distribution |
| 8412-0706 | Device Size Text, specify—ACDF PEEK 7° 14x17x6mm | In distribution |
| 8427-3516 | Device Size Text, specify—Screw Self-Drill Variable Ti ø3.5x16mm | In distribution |
| 8405-1202 | Device Size Text, specify—Locking Cap Ti 1.25mm High Angle | In distribution |
| 8417-0010 | Device Size Text, specify—ACDF PEEK 0° 12x15x10mm | In distribution |
| 8425-3514 | Device Size Text, specify—Screw Self-Drill Fixed Ti ø3.5x14mm | In distribution |
| 8424-3516 | Device Size Text, specify—Screw Self-Tap Fixed Ti ø3.5x16mm | In distribution |
| 8409-1210 | Device Size Text, specify—Full-Plate Ti 10° 10mm | In distribution |
| 8417-0007 | Device Size Text, specify—ACDF PEEK 0° 12x15x7mm | In distribution |
| 8417-0506 | Device Size Text, specify—ACDF PEEK 5° 12x15x6mm | In distribution |
| 8411-0705 | Device Size Text, specify—ACDF PEEK 7° 13x15x5mm | In distribution |
| 8409-1205 | Device Size Text, specify—Full-Plate Ti 10° 5mm | In distribution |
| 8411-0710 | Device Size Text, specify—ACDF PEEK 7° 13x15x10mm | In distribution |
| 8409-2110 | Device Size Text, specify—Half-Plate Caudal Ti 10mm | In distribution |
| 8424-4018 | Device Size Text, specify—Screw Self-Tap Fixed Ti ø4.0x18mm | In distribution |
| 8411-0709 | Device Size Text, specify—ACDF PEEK 7° 13x15x9mm | In distribution |
| 8409-2106 | Device Size Text, specify—Half-Plate Caudal Ti 6mm | In distribution |
| 8417-0510 | Device Size Text, specify—ACDF PEEK 5° 12x15x10mm | In distribution |
| 8411-0008 | Device Size Text, specify—ACDF PEEK 0° 13x15x8mm | In distribution |
| 8411-0512 | Device Size Text, specify—ACDF PEEK 5° 13x15x12mm | In distribution |
| 8427-3512 | Device Size Text, specify—Screw Self-Drill Variable Ti ø3.5x12mm | In distribution |
| 8412-0712 | Device Size Text, specify—ACDF PEEK 7° 14x17x12mm | In distribution |
| 8411-0506 | Device Size Text, specify—ACDF PEEK 5° 13x15x6mm | In distribution |
| 8426-3512 | Device Size Text, specify—Screw Self-Tap Variable Ti ø3.5x12mm | In distribution |
| 8417-0507 | Device Size Text, specify—ACDF PEEK 5° 12x15x7mm | In distribution |
| 8417-0008 | Device Size Text, specify—ACDF PEEK 0° 12x15x8mm | In distribution |
| 8411-0712 | Device Size Text, specify—ACDF PEEK 7° 13x15x12mm | In distribution |
| 8425-4018 | Device Size Text, specify—Screw Self-Drill Fixed Ti ø4.0x18mm | In distribution |
| 8412-0509 | Device Size Text, specify—ACDF PEEK 5° 14x17x9mm | In distribution |
| 8409-2108 | Device Size Text, specify—Half-Plate Caudal Ti 8mm | In distribution |
| 8426-4018 | Device Size Text, specify—Screw Self-Tap Variable Ti ø4.0x18mm | In distribution |
| 8411-0007 | Device Size Text, specify—ACDF PEEK 0° 13x15x7mm | In distribution |
| 8417-0512 | Device Size Text, specify—ACDF PEEK 5° 12x15x12mm | In distribution |
| 8411-0510 | Device Size Text, specify—ACDF PEEK 5° 13x15x10mm | In distribution |
| 8405-1205 | Device Size Text, specify—Locking Cap Ti 2.00mm High Angle | In distribution |
| 8411-0708 | Device Size Text, specify—ACDF PEEK 7° 13x15x8mm | In distribution |
| 8424-3518 | Device Size Text, specify—Screw Self-Tap Fixed Ti ø3.5x18mm | In distribution |
| 8409-1209 | Device Size Text, specify—Full-Plate Ti 10° 9mm | In distribution |
| 8417-0711 | Device Size Text, specify—ACDF PEEK 7° 12x15x11mm | In distribution |
| 8417-0708 | Device Size Text, specify—ACDF PEEK 7° 12x15x8mm | In distribution |
| 8412-0505 | Device Size Text, specify—ACDF PEEK 5° 14x17x5mm | In distribution |
| 8425-3512 | Device Size Text, specify—Screw Self-Drill Fixed Ti ø3.5x12mm | In distribution |
| 8417-0509 | Device Size Text, specify—ACDF PEEK 5° 12x15x9mm | In distribution |
| 8412-0011 | Device Size Text, specify—ACDF PEEK 0° 14x17x11mm | In distribution |
| 8412-0711 | Device Size Text, specify—ACDF PEEK 7° 14x17x11mm | In distribution |
| 8412-0708 | Device Size Text, specify—ACDF PEEK 7° 14x17x8mm | In distribution |
| 8427-3514 | Device Size Text, specify—Screw Self-Drill Variable Ti ø3.5x14mm | In distribution |
| 8412-0006 | Device Size Text, specify—ACDF PEEK 0° 14x17x6mm | In distribution |
| 8412-0009 | Device Size Text, specify—ACDF PEEK 0° 14x17x9mm | In distribution |
| 8412-0010 | Device Size Text, specify—ACDF PEEK 0° 14x17x10mm | In distribution |
| 8405-1203 | Device Size Text, specify—Locking Cap Ti 1.50mm High Angle | In distribution |
| 8409-1208 | Device Size Text, specify—Full-Plate Ti 10° 8mm | In distribution |
| 8409-2105 | Device Size Text, specify—Half-Plate Caudal Ti 5mm | In distribution |
| 8412-0005 | Device Size Text, specify—ACDF PEEK 0° 14x17x5mm | In distribution |
| 8411-0509 | Device Size Text, specify—ACDF PEEK 5° 13x15x9mm | In distribution |
| 8409-0007 | Device Size Text, specify—Zero-Plate Ti 7mm | In distribution |
| 8417-0009 | Device Size Text, specify—ACDF PEEK 0° 12x15x9mm | In distribution |
| 8425-4016 | Device Size Text, specify—Screw Self-Drill Fixed Ti ø4.0x16mm | In distribution |
| 8411-0508 | Device Size Text, specify—ACDF PEEK 5° 13x15x8mm | In distribution |
| 8411-0511 | Device Size Text, specify—ACDF PEEK 5° 13x15x11mm | In distribution |
| 8409-2107 | Device Size Text, specify—Half-Plate Caudal Ti 7mm | In distribution |
| 8411-0011 | Device Size Text, specify—ACDF PEEK 0° 13x15x11mm | In distribution |
| 8427-4012 | Device Size Text, specify—Screw Self-Drill Variable Ti ø4.0x12mm | In distribution |
| 8424-4014 | Device Size Text, specify—Screw Self-Tap Fixed Ti ø4.0x14mm | In distribution |
| 8417-0505 | Device Size Text, specify—ACDF PEEK 5° 12x15x5mm | In distribution |
| 8417-0511 | Device Size Text, specify—ACDF PEEK 5° 12x15x11mm | In distribution |
| 8409-1206 | Device Size Text, specify—Full-Plate Ti 10° 6mm | In distribution |
| 8411-0711 | Device Size Text, specify—ACDF PEEK 7° 13x15x11mm | In distribution |
| 8417-0707 | Device Size Text, specify—ACDF PEEK 7° 12x15x7mm | In distribution |
| 8412-0506 | Device Size Text, specify—ACDF PEEK 5° 14x17x6mm | In distribution |
| 8412-0012 | Device Size Text, specify—ACDF PEEK 0° 14x17x12mm | In distribution |
| 8427-4016 | Device Size Text, specify—Screw Self-Drill Variable Ti ø4.0x16mm | In distribution |
| 8405-1204 | Device Size Text, specify—Locking Cap Ti 1.75mm High Angle | In distribution |
| 8412-0512 | Device Size Text, specify—ACDF PEEK 5° 14x17x12mm | In distribution |
| 8424-3514 | Device Size Text, specify—Screw Self-Tap Fixed Ti ø3.5x14mm | In distribution |
| 8405-1000 | Device Size Text, specify—Locking Cap Ti | In distribution |
| 8425-3518 | Device Size Text, specify—Screw Self-Drill Fixed Ti ø3.5x18mm | In distribution |
| 8417-0012 | Device Size Text, specify—ACDF PEEK 0° 12x15x12mm | In distribution |
| 8417-0005 | Device Size Text, specify—ACDF PEEK 0° 12x15x5mm | In distribution |
| 8425-3516 | Device Size Text, specify—Screw Self-Drill Fixed Ti ø3.5x16mm | In distribution |
| 8426-3514 | Device Size Text, specify—Screw Self-Tap Variable Ti ø3.5x14mm | In distribution |
| 8412-0707 | Device Size Text, specify—ACDF PEEK 7° 14x17x7mm | In distribution |
| 8424-4012 | Device Size Text, specify—Screw Self-Tap Fixed Ti ø4.0x12mm | In distribution |
| 8409-2112 | Device Size Text, specify—Half-Plate Caudal Ti 12mm | In distribution |
| 8411-0706 | Device Size Text, specify—ACDF PEEK 7° 13x15x6mm | In distribution |
| 8417-0709 | Device Size Text, specify—ACDF PEEK 7° 12x15x9mm | In distribution |
| 8412-0709 | Device Size Text, specify—ACDF PEEK 7° 14x17x9mm | In distribution |
| 8411-0707 | Device Size Text, specify—ACDF PEEK 7° 13x15x7mm | In distribution |
| 8412-0511 | Device Size Text, specify—ACDF PEEK 5° 14x17x11mm | In distribution |
| 8409-1211 | Device Size Text, specify—Full-Plate Ti 10° 11mm | In distribution |
| 8412-0705 | Device Size Text, specify—ACDF PEEK 7° 14x17x5mm | In distribution |
| 8427-3518 | Device Size Text, specify—Screw Self-Drill Variable Ti ø3.5x18mm | In distribution |
| 8424-4016 | Device Size Text, specify—Screw Self-Tap Fixed Ti ø4.0x16mm | In distribution |
| 8424-3512 | Device Size Text, specify—Screw Self-Tap Fixed Ti ø3.5x12mm | In distribution |
| 8411-0012 | Device Size Text, specify—ACDF PEEK 0° 13x15x12mm | In distribution |
| 8411-0006 | Device Size Text, specify—ACDF PEEK 0° 13x15x6mm | In distribution |
| 8426-3516 | Device Size Text, specify—Screw Self-Tap Variable Ti ø3.5x16mm | In distribution |
| 8411-0507 | Device Size Text, specify—ACDF PEEK 5° 13x15x7mm | In distribution |
| 8411-0005 | Device Size Text, specify—ACDF PEEK 0° 13x15x5mm | In distribution |
| 8427-4018 | Device Size Text, specify—Screw Self-Drill Variable Ti ø4.0x18mm | In distribution |
| 8412-0507 | Device Size Text, specify—ACDF PEEK 5° 14x17x7mm | In distribution |
| 8425-4014 | Device Size Text, specify—Screw Self-Drill Fixed Ti ø4.0x14mm | In distribution |
| 8411-0009 | Device Size Text, specify—ACDF PEEK 0° 13x15x9mm | In distribution |
| 8426-4016 | Device Size Text, specify—Screw Self-Tap Variable Ti ø4.0x16mm | In distribution |
| 8411-0505 | Device Size Text, specify—ACDF PEEK 5° 13x15x5mm | In distribution |
| 8409-2111 | Device Size Text, specify—Half-Plate Caudal Ti 11mm | In distribution |
| 8426-4012 | Device Size Text, specify—Screw Self-Tap Variable Ti ø4.0x12mm | In distribution |
| 8426-3518 | Device Size Text, specify—Screw Self-Tap Variable Ti ø3.5x18mm | In distribution |
| 8425-4012 | Device Size Text, specify—Screw Self-Drill Fixed Ti ø4.0x12mm | In distribution |
| 8417-0706 | Device Size Text, specify—ACDF PEEK 7° 12x15x6mm | In distribution |
| 8411-0010 | Device Size Text, specify—ACDF PEEK 0° 13x15x10mm | In distribution |
| 8412-0710 | Device Size Text, specify—ACDF PEEK 7° 14x17x10mm | In distribution |
| 8426-4014 | Device Size Text, specify—Screw Self-Tap Variable Ti ø4.0x14mm | In distribution |
| 8417-0710 | Device Size Text, specify—ACDF PEEK 7° 12x15x10mm | In distribution |
| 8417-0508 | Device Size Text, specify—ACDF PEEK 5° 12x15x8mm | In distribution |
| 8412-0008 | Device Size Text, specify—ACDF PEEK 0° 14x17x8mm | In distribution |
| 8412-0007 | Device Size Text, specify—ACDF PEEK 0° 14x17x7mm | In distribution |
| 8412-0508 | Device Size Text, specify—ACDF PEEK 5° 14x17x8mm | In distribution |
| 8417-0011 | Device Size Text, specify—ACDF PEEK 0° 12x15x11mm | In distribution |
| 8409-1212 | Device Size Text, specify—Full-Plate Ti 10° 12mm | In distribution |
| 8417-0006 | Device Size Text, specify—ACDF PEEK 0° 12x15x6mm | In distribution |
| 8412-0510 | Device Size Text, specify—ACDF PEEK 5° 14x17x10mm | In distribution |
| 8409-0006 | Device Size Text, specify—Zero-Plate Ti 6mm | In distribution |
| 8417-0705 | Device Size Text, specify—ACDF PEEK 7° 12x15x5mm | In distribution |
| 8409-1207 | Device Size Text, specify—Full-Plate Ti 10° 7mm | In distribution |
| 8417-0712 | Device Size Text, specify—ACDF PEEK 7° 12x15x12mm | In distribution |
| 8427-4014 | Device Size Text, specify—Screw Self-Drill Variable Ti ø4.0x14mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| IdentiTi | Alphatec Spine, Inc. | 630 |
| Dolomite | Astura Medical | 607 |
| CoRoent | Nuvasive, Inc. | 580 |
| Aeon-C | Diomedical Co., Ltd. | 508 |
| Tomcat™ Cervical Spinal System | Choice Spine, LP | 468 |
| Shoreline ACS | Seaspine Orthopedics Corporation | 428 |
| Zavation | Zavation | 423 |
| Alta™ Stand-Alone Interbody Fusion System | Biomet Spine | 404 |
| Unison™-C Anterior Cervical Fixation System | Pioneer Surgical Technology, Inc. | 334 |
| Chesapeake® Stabilization System | VB Spine LLC | 272 |
| UniSpace® Stand-Alone C Cage | CG MedTech Co., Ltd. | 260 |
| Solitaire-C Cervical Spacer | Biomet Spine | 256 |
Showing 12 of 391. All products under Intervertebral Fusion Device With Integrated Fixation, Cervical
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.