InterForm Cervical Interbody Cage System
510(k) K161608
InterForm Cervical Interbody Cage System is a Class II device made by Next Orthosurgical, cleared under FDA 510(k) K161608 on 30 Sep 2016, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK161608 | Date30 Sep 2016 | StatusActive |
Official records
- FDA 510(k) database K161608
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- ODP
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3080
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K161608
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| EZ-Track CJAB141205A | CJAB141205A / CJAB141205A | 00840314136909 | Width 14 mm; Length 12 mm; Height 5 mm; Angle 0 deg | On the market |
| EZ-Track CJAB141205G | CJAB141205G / CJAB141205G | 00840314137142 | Width 14 mm; Length 12 mm; Height 5 mm; Angle 6 deg | On the market |
| EZ-Track CJAB141206A | CJAB141206A / CJAB141206A | 00840314136916 | Width 14 mm; Length 12 mm; Height 6 mm; Angle 0 deg | On the market |
| EZ-Track CJAB141206G | CJAB141206G / CJAB141206G | 00840314137159 | Width 14 mm; Length 12 mm; Height 6 mm; Angle 6 deg | On the market |
| EZ-Track CJAB141208A | CJAB141208A / CJAB141208A | 00840314136930 | Width 14 mm; Length 12 mm; Height 8 mm; Angle 0 deg | On the market |
| EZ-Track CJAB141209A | CJAB141209A / CJAB141209A | 00840314136947 | Width 14 mm; Length 12 mm; Height 8 mm; Angle 0 deg | On the market |
| EZ-Track CJAB141209G | CJAB141209G / CJAB141209G | 00840314137180 | Width 14 mm; Length 12 mm; Height 9 mm; Angle 6 deg | On the market |
| EZ-Track CJAB141210G | CJAB141210G / CJAB141210G | 00840314137197 | Width 14 mm; Length 12 mm; Height 10 mm; Angle 6 deg | On the market |
| EZ-Track CJAB151305A | CJAB151305A / CJAB151305A | 00840314136985 | Width 15 mm; Length 13 mm; Height 5 mm; Angle 0 deg | On the market |
| EZ-Track CJAB151305G | CJAB151305G / CJAB151305G | 00840314137227 | Width 15 mm; Length 13 mm; Height 5 mm; Angle 6 deg | On the market |
| EZ-Track CJAB151306A | CJAB151306A / CJAB151306A | 00840314136992 | Width 15 mm; Length 13 mm; Height 6 mm; Angle 0 deg | On the market |
| EZ-Track CJAB151306G | CJAB151306G / CJAB151306G | 00840314137234 | Width 15 mm; Length 13 mm; Height 6 mm; Angle 6 deg | On the market |
| EZ-Track CJAB151308G | CJAB151308G / CJAB151308G | 00840314137258 | Width 15 mm; Length 13 mm; Height 8 mm; Angle 6 deg | On the market |
| EZ-Track CJAB151310G | CJAB151310G / CJAB151310G | 00840314137272 | Width 15 mm; Length 13 mm; Height 10 mm; Angle 6 deg | On the market |
| EZ-Track CJAB151311A | CJAB151311A / CJAB151311A | 00840314137043 | Width 15 mm; Length 13 mm; Height 11 mm; Angle 0 deg | On the market |
| EZ-Track CJAB151312A | CJAB151312A / CJAB151312A | 00840314137050 | Width 15 mm; Length 13 mm; Angle 0 deg; Height 12 mm | On the market |
| EZ-Track CJAB161407A | CJAB161407A / CJAB161407A | 00840314137081 | Width 16 mm; Length 14 mm; Height 7 mm; Angle 0 deg | On the market |
| EZ-Track CJAB161408A | CJAB161408A / CJAB161408A | 00840314137098 | Width 16 mm; Length 14 mm; Height 8 mm; Angle 0 deg | On the market |
| EZ-Track CJAB161408G | CJAB161408G / CJAB161408G | 00840314137333 | Width 16 mm; Length 14 mm; Height 8 mm; Angle 6 deg | On the market |
| EZ-Track CJAB161410A | CJAB161410A / CJAB161410A | 00840314137111 | Width 16 mm; Length 14 mm; Height 10 mm; Angle 0 deg | On the market |
| EZ-Track CJAB161410G | CJAB161410G / CJAB161410G | 00840314137357 | Width 16 mm; Length 14 mm; Height 10 mm; Angle 6 deg | On the market |
| EZ-Track CJAB161411A | CJAB161411A / CJAB161411A | 00840314137128 | Weight 16 Milligram; Length 14 mm; Height 11 mm; Angle 0 deg | On the market |
| EZ-Track CJAB161412G | CJAB161412G / CJAB161412G | 00840314137371 | Width 16 mm; Length 14 mm; Height 12 mm; Angle 6 deg | On the market |
| EZ-Track CJBB141206G | CJBB141206G / CJBB141206G | 00840314137630 | Width 14 mm; Length 12 mm; Height 6 mm; Angle 6 deg | On the market |
| EZ-Track CJBB141207A | CJBB141207A / CJBB141207A | 00840314137401 | Width 14 mm; Length 12 mm; Height 7 mm; Angle 0 deg | On the market |
| EZ-Track CJBB141208A | CJBB141208A / CJBB141208A | 00840314137418 | Width 14 mm; Length 12 mm; Height 8 mm; Angle 0 deg | On the market |
| EZ-Track CJBB141208G | CJBB141208G / CJBB141208G | 00840314137654 | Width 14 mm; Length 12 mm; Height 8 mm; Angle 6 deg | On the market |
| EZ-Track CJBB141209A | CJBB141209A / CJBB141209A | 00840314137425 | Width 14 mm; Length 12 mm; Height 9 mm; Angle 0 deg | On the market |
| EZ-Track CJBB141210A | CJBB141210A / CJBB141210A | 00840314137432 | Length 12 mm; Height 10 mm; Angle 0 deg; Width 14 mm | On the market |
| EZ-Track CJBB141211A | CJBB141211A / CJBB141211A | 00840314137449 | Width 14 mm; Length 12 mm; Height 11 mm; Angle 0 deg | On the market |
| EZ-Track CJBB141211G | CJBB141211G / CJBB141211G | 00840314137685 | Width 14 mm; Length 12 mm; Height 11 mm; Angle 6 deg | On the market |
| EZ-Track CJBB141212A | CJBB141212A / CJBB141212A | 00840314137456 | Width 14 mm; Length 12 mm; Height 12 mm; Angle 0 deg | On the market |
| EZ-Track CJBB141212G | CJBB141212G / CJBB141212G | 00840314137692 | Width 14 mm; Length 12 mm; Height 12 mm; Angle 6 deg | On the market |
| EZ-Track CJBB151307A | CJBB151307A / CJBB151307A | 00840314137487 | Width 15 mm; Length 13 mm; Height 7 mm; Angle 0 deg | On the market |
| EZ-Track CJBB151308A | CJBB151308A / CJBB151308A | 00840314137494 | Width 15 mm; Length 13 mm; Height 8 mm; Angle 0 deg | On the market |
| EZ-Track CJBB151308G | CJBB151308G / CJBB151308G | 00840314137739 | Width 15 mm; Length 13 mm; Height 8 mm; Angle 6 deg | On the market |
| EZ-Track CJBB151309A | CJBB151309A / CJBB151309A | 00840314137500 | Width 15 mm; Length 13 mm; Height 9 mm; Angle 0 deg | On the market |
| EZ-Track CJBB151310G | CJBB151310G / CJBB151310G | 00840314137753 | Width 15 mm; Length 13 mm; Height 10 mm; Angle 6 deg | On the market |
| EZ-Track CJBB151311G | CJBB151311G / CJBB151311G | 00840314137760 | Width 15 mm; Length 13 mm; Height 11 mm; Angle 6 deg | On the market |
| EZ-Track CJBB161405A | CJBB161405A / CJBB161405A | 00840314137548 | Width 16 mm; Length 14 mm; Height 5 mm; Angle 0 deg | On the market |
| EZ-Track CJBB161405G | CJBB161405G / CJBB161405G | 00840314137784 | Width 16 mm; Length 14 mm; Height 5 mm; Angle 6 deg | On the market |
| EZ-Track CJBB161406A | CJBB161406A / CJBB161406A | 00840314137555 | Width 16 mm; Length 14 mm; Height 6 mm; Angle 0 deg | On the market |
| EZ-Track CJBB161407A | CJBB161407A / CJBB161407A | 00840314137562 | Width 16 mm; Length 14 mm; Height 7 mm; Angle 0 deg | On the market |
| EZ-Track CJBB161408A | CJBB161408A / CJBB161408A | 00840314137579 | Width 16 mm; Length 14 mm; Height 8 mm; Angle 0 deg | On the market |
| EZ-Track CJBB161409A | CJBB161409A / CJBB161409A | 00840314137586 | Width 16 mm; Length 14 mm; Height 9 mm; Angle 0 deg | On the market |
| EZ-Track CJBB161410A | CJBB161410A / CJBB161410A | 00840314137593 | Width 16 mm; Length 14 mm; Height 10 mm; Angle 0 deg | On the market |
| EZ-Track CJBB161410G | CJBB161410G / CJBB161410G | 00840314137838 | Width 16 mm; Length 14 mm; Height 10 mm; Angle 6 deg | On the market |
| EZ-Track CJBB161411A | CJBB161411A / CJBB161411A | 00840314137609 | Width 16 mm; Length 14 mm; Height 11 mm; Angle 0 deg | On the market |
| EZ-Track CJBB161411G | CJBB161411G / CJBB161411G | 00840314137845 | Width 16 mm; Length 14 mm; Height 11 mm; Angle 6 deg | On the market |
| EZ-Track CJBB161412A | CJBB161412A / CJBB161412A | 00840314137616 | Width 16 mm; Length 14 mm; Height 12 mm; Angle 0 deg | On the market |
Similar devices
Other devices filed under FDA product code ODP (Intervertebral Fusion Device With Bone Graft, Cervical).
- Mecta-C Ti mark 03.28.328 by Medacta International SA
- ALEUTIAN® Interbody Systems 3303-90152 by VB Spine LLC
- Mecta-C Cervical Ti-Peek Cages 03.28.616 by Medacta International SA
- NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody System; NuVasive CoRoent Small Interlock System; NuVasive CoRoent Small Interlock II System; NuVasive CoRoent Small Ti-C System; NuVasive Cohere Cervical Interbody System by Nu Vasive, Incorporated
- CONDUIT Cages; FIBERGRAFT BG Putty by Depuy Spine, Inc.
- Curiteva Porous PEEK Cervical Interbody Fusion System by Curiteva, LLC
- Vertera Spine Cohere Cervical Interbody Fusion Device by Nu Vasive, Incorporated
- STINGRAY CERVICAL CAGE by Omni Surgical, LLC Dba Spine360
- VariLift®-C Interbody Fusion System by Wenzel Spine
- Ti3Z Cervical Interbody System by Zavation Medical Products, LLC