Evos Lumbar Interbody System
EVOS is a lumbar interbody fusion system with PEEK implants placed through a posterior or transforaminal approach. Its spacers contain an internal graft cavity with openings through the…
EVOS is a lumbar interbody fusion system with PEEK implants placed through a posterior or transforaminal approach. Its spacers contain an internal graft cavity with openings through the top, bottom and sides.
Surface teeth engage the vertebral endplates and resist backing out. The implants use PEEK-OPTIMA LT1 or HA Enhanced material, with embedded tantalum beads to show their position on radiographs.
Listed Item
HA PEEK EVOS Straight, ,15mmx10mmx 30mm , FLAT 5 ° (TOL) , Narrow Nose
Shapes and Placement
The family includes STRAIGHT, CURVED and ROTATE forms, with different sizes, endplate shapes and lordotic angles. CURVED implants are placed singly; STRAIGHT and ROTATE implants may be used singly or in pairs. The sterile, single-use spacers are used with autologous bone graft and supplemental fixation.
14manufacturers in China registered for this device type
1,871catalogue numbers in this listing
6510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (6), Shandong (2), Shanghai (2). 7 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 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Suzhou Ahno Medical Devices Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 17 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Jiangsu Ideal Medical Science & Technology Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 7 |
| Zhisu Health Tech Jiaxing Co., Ltd. | Tongxiang | Zhejiang | Contract manufacturer | 4 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Shanghai Reach Medical Instrument Co., Ltd. | Shanghai | Shanghai | Manufacturer | 30 |
| Changzhou Geasure Medical Apparatus AND Instruments Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 25 |
| Double Medical Technology Inc. | Xiamen | Fujian | Contract manufacturer | 14 |
| Zhejiang Decans Medical Devices Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 10 |
Showing 12 of 14. All 14 manufacturers in China registered for Intervertebral Fusion Device With Bone Graft, Lumbar
Record
| Listed by | Cutting Edge Spine, United States |
|---|---|
| FDA product code | MAX |
| Device type | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K150321 |
| Record published | 2015-10-30 |
| Record revised | 2024-09-11 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Special storage condition: Store at room temperature |
| Sizes | Length 14 to 600 mm; length 14 to 22 in |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 4028-011 | Length 30 mm | In distribution |
| 4304-011 | Length 30 mm | In distribution |
| 4200-010 | Length 22 mm | In distribution |
| 4114-010 | Length 26 mm | In distribution |
| 4277-010 | Length 22 mm | In distribution |
| 4121-012 | Length 26 mm | In distribution |
| 4117-011 | Length 26 mm | In distribution |
| 4310-016 | Length 30 mm | In distribution |
| 4226-010 | Length 22 mm | In distribution |
| 4406-015 | Length 30 mm | In distribution |
| 4319-011 | Length 30 mm | In distribution |
| 4016-007 | Length 22 mm | In distribution |
| 4226-009 | Length 22 mm | In distribution |
| 4027-016 | Length 26 mm | In distribution |
| 4195-016 | Length 30 mm | In distribution |
| 4517-016 | Length 26 mm | In distribution |
| 4054-016 | Length 26 mm | In distribution |
| 4202-012 | Length 30 mm | In distribution |
| 4301-010 | Length 30 mm | In distribution |
| 4320-016 | Length 30 mm | In distribution |
| 4201-008 | Length 26 mm | In distribution |
| 4615-011 | Length 26 mm | In distribution |
| 4303-011 | Length 30 mm | In distribution |
| 4023-014 | Length 26 mm | In distribution |
| 4303-015 | Length 30 mm | In distribution |
| 4104-007 | Length 26 mm | In distribution |
| 4002-007 | Length 30 mm | In distribution |
| 4217-012 | Length 26 mm | In distribution |
| 4224-016 | Length 22 mm | In distribution |
| 4002-011 | Length 30 mm | In distribution |
| 4119-016 | Length 26 mm | In distribution |
| 4002-010 | Length 30 mm | In distribution |
| 4307-009 | Length 30 mm | In distribution |
| 4201-009 | Length 26 mm | In distribution |
| 4115-015 | Length 26 mm | In distribution |
| 4127-014 | Length 26 mm | In distribution |
| 4226-011 | Length 22 mm | In distribution |
| 4309-016 | Length 30 mm | In distribution |
| 4004-007 | Length 26 mm | In distribution |
| 4313-011 | Length 30 mm | In distribution |
| 4814-012 | Length 22 mm | In distribution |
| 4212-010 | Length 22 mm | In distribution |
| 4387-014 | Length 22 mm | In distribution |
| 4008-010 | Length 30 mm | In distribution |
| 4285-012 | Length 30 mm | In distribution |
| 4416-016 | Length 22 mm | In distribution |
| 4068-010 | Length 26 mm | In distribution |
| 4131-009 | Length 30 mm | In distribution |
| 4714-011 | Length 22 mm | In distribution |
| 4388-015 | Length 22 mm | In distribution |
| 4069-015 | Length 30 mm | In distribution |
| 4065-014 | Length 30 mm | In distribution |
| 4104-008 | Length 26 mm | In distribution |
| 4102-008 | Length 26 mm | In distribution |
| 4616-013 | Length 22 mm | In distribution |
| 4211-010 | Length 30 mm | In distribution |
| 4186-014 | Length 26 mm | In distribution |
| 4125-011 | Length 26 mm | In distribution |
| 4117-014 | Length 26 mm | In distribution |
| 4083-011 | Length 30 mm | In distribution |
| 4283-013 | Length 22 mm | In distribution |
| 4316-015 | Length 30 mm | In distribution |
| 4416-015 | Length 22 mm | In distribution |
| 4205-008 | Length 30 mm | In distribution |
| 4084-012 | Length 26 mm | In distribution |
| 4215-012 | Length 30 mm | In distribution |
| 4478-016 | Length 22 mm | In distribution |
| 4315-014 | Length 30 mm | In distribution |
| 4914-013 | Length 22 mm | In distribution |
| 4006-011 | Length 22 mm | In distribution |
| 4229-011 | Length 30 mm | In distribution |
| 4056-012 | Length 26 mm | In distribution |
| 4197-014 | Length 30 mm | In distribution |
| 4031-008 | Length 26 mm | In distribution |
| 4103-013 | Length 26 mm | In distribution |
| 4206-007 | Length 22 mm | In distribution |
| CES-506 | Length 600 mm | In distribution |
| 4050-007 | Length 26 mm | In distribution |
| 4073-015 | Length 30 mm | In distribution |
| 4130-010 | Length 30 mm | In distribution |
| 4491-013 | Length 30 mm | In distribution |
| 4216-015 | Length 30 mm | In distribution |
| 4060-010 | Length 26 mm | In distribution |
| 4380-010 | Length 22 mm | In distribution |
| 4059-013 | Length 30 mm | In distribution |
| 4110-006 | Length 26 mm | In distribution |
| 4212-014 | Length 22 mm | In distribution |
| 4066-016 | Length 26 mm | In distribution |
| 4021-016 | Length 26 mm | In distribution |
| 4112-013 | Length 26 mm | In distribution |
| 4300-012 | Length 30 mm | In distribution |
| 4316-011 | Length 30 mm | In distribution |
| 4416-011 | Length 22 mm | In distribution |
| 4206-012 | Length 22 mm | In distribution |
| 4308-014 | Length 30 mm | In distribution |
| 4105-011 | Length 26 mm | In distribution |
| 4101-013 | Length 26 mm | In distribution |
| 4312-012 | Length 30 mm | In distribution |
| 4175-012 | Length 30 mm | In distribution |
| 4303-013 | Length 30 mm | In distribution |
| 4220-015 | Length 22 mm | In distribution |
| 4218-012 | Length 22 mm | In distribution |
| 4212-012 | Length 22 mm | In distribution |
| 4060-012 | Length 26 mm | In distribution |
| 4083-012 | Length 30 mm | In distribution |
| 4061-009 | Length 30 mm | In distribution |
| 4490-012 | Length 26 mm | In distribution |
| 4106-011 | Length 26 mm | In distribution |
| 4308-011 | Length 30 mm | In distribution |
| 4014-016 | Length 22 mm | In distribution |
| 4018-010 | Length 22 mm | In distribution |
| 4109-007 | Length 26 mm | In distribution |
| 4107-010 | Length 26 mm | In distribution |
| 4516-013 | Length 22 mm | In distribution |
| 4025-011 | Length 26 mm | In distribution |
| 4608-012 | Length 30 mm | In distribution |
| 4013-013 | Length 26 mm | In distribution |
| 4062-011 | Length 26 mm | In distribution |
| 4287-016 | Length 26 mm | In distribution |
| 4071-009 | Length 30 mm | In distribution |
| 4417-010 | Length 26 mm | In distribution |
| 4005-014 | Length 30 mm | In distribution |
| 4017-010 | Length 26 mm | In distribution |
| 4227-012 | Length 26 mm | In distribution |
| 4317-016 | Length 30 mm | In distribution |
| 4504-011 | Length 30 mm | In distribution |
| 4814-011 | Length 22 mm | In distribution |
| 4514-016 | Length 22 mm | In distribution |
| 4387-012 | Length 22 mm | In distribution |
| 4393-016 | Length 22 mm | In distribution |
| 4060-007 | Length 30 mm | In distribution |
| 4318-009 | Length 30 mm | In distribution |
| 4482-014 | Length 22 mm | In distribution |
| 4123-016 | Length 26 mm | In distribution |
| 4517-010 | Length 26 mm | In distribution |
| 4073-011 | Length 30 mm | In distribution |
| 4113-014 | Length 26 mm | In distribution |
| 4001-014 | Length 26 mm | In distribution |
| 4221-013 | Length 26 mm | In distribution |
| 4125-014 | Length 26 mm | In distribution |
| 4224-011 | Length 22 mm | In distribution |
| 4062-008 | Length 26 mm | In distribution |
| 4222-009 | Length 22 mm | In distribution |
| 4121-008 | Length 26 mm | In distribution |
| 4005-009 | Length 30 mm | In distribution |
| 4125-008 | Length 26 mm | In distribution |
| 4052-011 | Length 26 mm | In distribution |
| 4008-011 | Length 30 mm | In distribution |
| 4201-010 | Length 26 mm | In distribution |
| 4814-015 | Length 22 mm | In distribution |
| 4196-014 | Length 26 mm | In distribution |
| 4026-012 | Length 22 mm | In distribution |
| 4210-007 | Length 26 mm | In distribution |
| 4210-012 | Length 26 mm | In distribution |
| 4003-010 | Length 22 mm | In distribution |
| 4314-014 | Length 30 mm | In distribution |
| 4323-011 | Length 30 mm | In distribution |
| 4055-016 | Length 30 mm | In distribution |
| 4003-015 | Length 22 mm | In distribution |
| 4315-011 | Length 30 mm | In distribution |
| 4916-012 | Length 22 mm | In distribution |
| 4189-014 | Length 30 mm | In distribution |
| 4199-014 | Length 30 mm | In distribution |
| 4057-008 | Length 30 mm | In distribution |
| 4475-011 | Length 22 mm | In distribution |
| 4916-013 | Length 22 mm | In distribution |
| 4015-009 | Length 26 mm | In distribution |
| 4199-015 | Length 30 mm | In distribution |
| 4064-009 | Length 26 mm | In distribution |
| 4125-012 | Length 26 mm | In distribution |
| 4017-012 | Length 26 mm | In distribution |
| 4123-009 | Length 26 mm | In distribution |
| 4615-013 | Length 26 mm | In distribution |
| 4064-010 | Length 26 mm | In distribution |
| 4224-010 | Length 22 mm | In distribution |
| 4028-009 | Length 30 mm | In distribution |
| 4228-011 | Length 30 mm | In distribution |
| 4229-008 | Length 30 mm | In distribution |
| 4053-013 | Length 30 mm | In distribution |
| 4317-011 | Length 30 mm | In distribution |
| 4021-008 | Length 26 mm | In distribution |
| 4100-014 | Length 26 mm | In distribution |
| 4815-012 | Length 26 mm | In distribution |
| CES-258 | Length 14 in | In distribution |
| 4205-009 | Length 30 mm | In distribution |
| 4054-009 | Length 26 mm | In distribution |
| 4089-014 | Length 30 mm | In distribution |
| 4216-011 | Length 30 mm | In distribution |
| 4028-015 | Length 30 mm | In distribution |
| 4615-016 | Length 26 mm | In distribution |
| 4301-012 | Length 30 mm | In distribution |
| 4026-010 | Length 22 mm | In distribution |
| 4129-012 | Length 30 mm | In distribution |
| 4014-013 | Length 22 mm | In distribution |
| 4311-014 | Length 30 mm | In distribution |
| 4066-015 | Length 26 mm | In distribution |
| 4377-013 | Length 22 mm | In distribution |
| 4014-014 | Length 22 mm | In distribution |
| 4027-008 | Length 26 mm | In distribution |
| 4415-013 | Length 26 mm | In distribution |
| 4313-009 | Length 30 mm | In distribution |
| 4321-011 | Length 30 mm | In distribution |
| 4031-013 | Length 26 mm | In distribution |
| 4116-011 | Length 26 mm | In distribution |
| 4515-014 | Length 26 mm | In distribution |
| 4122-010 | Length 26 mm | In distribution |
| 4053-011 | Length 30 mm | In distribution |
| 4062-009 | Length 26 mm | In distribution |
| 4100-010 | Length 26 mm | In distribution |
| 4310-015 | Length 30 mm | In distribution |
| 4126-009 | Length 22 mm | In distribution |
| 4203-009 | Length 22 mm | In distribution |
| 4196-013 | Length 26 mm | In distribution |
| 4093-010 | Length 30 mm | In distribution |
| 4122-013 | Length 26 mm | In distribution |
| 4908-014 | Length 30 mm | In distribution |
| 4129-009 | Length 30 mm | In distribution |
| 4072-010 | Length 26 mm | In distribution |
| 4287-014 | Length 26 mm | In distribution |
| 4311-011 | Length 30 mm | In distribution |
| 4815-013 | Length 26 mm | In distribution |
| 4230-015 | Length 30 mm | In distribution |
| 4128-014 | Length 30 mm | In distribution |
| 4106-013 | Length 26 mm | In distribution |
| 4507-016 | Length 30 mm | In distribution |
| 4127-012 | Length 26 mm | In distribution |
| 4081-011 | Length 30 mm | In distribution |
| 4212-016 | Length 22 mm | In distribution |
| 4008-009 | Length 30 mm | In distribution |
| 4017-013 | Length 26 mm | In distribution |
| 4058-012 | Length 26 mm | In distribution |
| 4230-012 | Length 30 mm | In distribution |
| 4320-010 | Length 30 mm | In distribution |
| 4117-016 | Length 26 mm | In distribution |
| 4207-016 | Length 26 mm | In distribution |
| CES-498 | Length 600 mm | In distribution |
| 4007-009 | Length 26 mm | In distribution |
| 4120-010 | Length 26 mm | In distribution |
| 4016-013 | Length 22 mm | In distribution |
| 4105-007 | Length 26 mm | In distribution |
| 4317-010 | Length 30 mm | In distribution |
| 4305-011 | Length 30 mm | In distribution |
| 4213-009 | Length 26 mm | In distribution |
| 4117-009 | Length 26 mm | In distribution |
| 4223-013 | Length 26 mm | In distribution |
| 4617-016 | Length 26 mm | In distribution |
| 4804-014 | Length 30 mm | In distribution |
| 4023-010 | Length 26 mm | In distribution |
| 4010-011 | Length 26 mm | In distribution |
| 4102-009 | Length 26 mm | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Peridot Intervertebral body fusion system | Gbs Commonwealth Co., Ltd. | 10,850 |
| Yellowstone | Summit Spine | 6,654 |
| CoRoent | Nuvasive, Inc. | 5,690 |
| Zavation | Zavation | 2,554 |
| Anyplus II Spinal Fixation System | GS Medical Co., Ltd. | 2,533 |
| Talos® IBF | Meditech Spine, LLC | 2,163 |
| Peridot-PT Intervertebral body fusion system | Gbs Commonwealth Co., Ltd. | 1,956 |
| TirboLOX-L Lumbar Ibfd | Captiva Spine, Inc. | 1,926 |
| Endoskeleton® TL | Titan Spine, LLC | 1,896 |
| Epiphany | Pantheon Spinal LLC | 1,507 |
| LnK Lumbar Interbody Fusion Cage System | L&K Biomed Co., Ltd. | 1,506 |
| LnK Lumbar Interbody Fusion Cage System/PathLoc-LC Lateral Cage System | L&K Biomed Co., Ltd. | 1,410 |
Showing 12 of 1,958. All products under Intervertebral Fusion Device With Bone Graft, Lumbar
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K200991 | 2020-05-13 |
| K200552 | 2020-04-02 |
| K192497 | 2020-01-06 |
| K180891 | 2018-05-04 |
| K150321 | 2015-07-13 |
| K102957 | 2011-04-28 |
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
| PMA number | Decision | Trade name | Approved to |
|---|---|---|---|
| P000028 | 2004-06-18 | AFFINITY ANTERIOR CERVICAL CAGE SYSTEM | Medtronic Sofamor Danek USA, Inc. |
| P970015 | 2003-09-10 | LT-CAGE PEEK LUMBAR TAPERED FUSION DEVICE | Sofamor Danek |
| P980048 | 2001-04-20 | BAK/CERVICAL (BAK/C) INTERBODY FUSION SYSTEM | Sulzer Spine-Tech |
| P950019 | 1999-03-19 | RAY THREADED FUSION CAGE (TFC) DEVICE WITH INSTRUMENTATION | Stryker Spine |
| P950002 | 1997-06-30 | BAK INTERBODY FUSION SYSTEM | Zimmer Spine, Inc. |
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.