Exactech Cervical Spacer System
510(k) K141129
Exactech Cervical Spacer System is a Class II device made by Exactech, Inc., cleared under FDA 510(k) K141129 on 15 Aug 2014, 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 | NumberK141129 | Date15 Aug 2014 | StatusActive |
Official records
- FDA 510(k) database K141129
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- Withdrawn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 K141129
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 | |||
|---|---|---|---|---|
| ASCENDANT 05-099-31-1407N | 05-099-31-1407N | 00840996184243 | — | On the market |
| ASCENDANT 05-099-31-1408N | 05-099-31-1408N | 00840996184250 | — | On the market |
| ASCENDANT 05-099-31-1409N | 05-099-31-1409N | 00840996184267 | — | On the market |
| ASCENDANT 05-099-31-1410N | 05-099-31-1410N | 00840996184274 | — | On the market |
| ASCENDANT 05-099-31-1411N | 05-099-31-1411N | 00840996184281 | — | On the market |
| ASCENDANT 05-099-31-1412N | 05-099-31-1412N | 00840996184298 | — | On the market |
| ASCENDANT 05-099-31-1605N | 05-099-31-1605N | 00840996184304 | — | On the market |
| ASCENDANT 05-099-31-1606N | 05-099-31-1606N | 00840996184311 | — | On the market |
| ASCENDANT 05-099-31-1607N | 05-099-31-1607N | 00840996184328 | — | On the market |
| ASCENDANT 05-099-31-1608N | 05-099-31-1608N | 00840996184335 | — | On the market |
| ASCENDANT 05-099-31-1609N | 05-099-31-1609N | 00840996184342 | — | On the market |
| ASCENDANT 05-099-31-1610N | 05-099-31-1610N | 00840996184359 | — | On the market |
| ASCENDANT 05-099-31-1611N | 05-099-31-1611N | 00840996184366 | — | On the market |
| ASCENDANT 05-099-31-1612N | 05-099-31-1612N | 00840996184373 | — | On the market |
Similar devices
Other devices filed under FDA product code ODP (Intervertebral Fusion Device With Bone Graft, Cervical).
- NuVasive CoRoent Small Ti-C System by Nu Vasive, Incorporated
- SPIRA-C Open Matrix Cervical Interbody by CAMBER SPINE TECHNOLOGIES
- ENDOSKELETON® TC nanoLOCK® Surface Technology 5186-1609-N by MEDTRONIC SOFAMOR DANEK, INC.
- Talos-C(HA) Cervical Intervertebral Body Fusion Devices by MEDITECH SPINE, LLC
- POROSTEON PHUSION METAL CERVICAL CAGE by Porosteon, Inc.
- CarboClear Posterior Cervical Screw System Ti Rod CRT4200 by CARBOFIX ORTHOPEDICS LTD
- ZAVATION IBF SYSTEMS by ZAVATION
- SeaSpine Cambria System by SeaSpine Orthopedics Corporation
- Ackermann Intervertebral Body Fusion Device by Ackermann Instrumente GmbH
- Mecta-C Cervical Ti-Peek Cages 03.28.629 by Medacta International SA