Vertex Reconstruction System
by Medtronic Sofamor Danek, Inc. 6 variants
510(k) K083071
Vertex Reconstruction System is a Class II device made by Medtronic Sofamor Danek, Inc., cleared under FDA 510(k) K083071 on 14 Nov 2008, active as of 22 Oct 2026. One FDA recall is linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK083071 | Date14 Nov 2008 | StatusActive |
Official records
- FDA 510(k) database K083071
Recalls
-
- Terminated Z-1826-2016
Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile. If the product becomes non-sterile and is used or implanted, it may lead to an infection.
Timeline
- Cleared FDA 510(k) K083071
- Recall initiated FDA recalls Z-1826-2016
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- KWP
- FDA applicant
- Medtronic Sofamor Danek
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3050
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K083071
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 | |||
|---|---|---|---|---|
| VERTEX® Reconstruction System 6958730PT | 6958730PT | 00613994356741 | — | On the market |
| VERTEX® Reconstruction System 6958742 | 6958742 | 00613994354907 | — | On the market |
| VERTEX® Reconstruction System 6958746 | 6958746 | 00613994354884 | — | On the market |
| VERTEX® Reconstruction System 6958752PT | 6958752PT | 00613994356635 | — | No longer on the market |
| VERTEX® Reconstruction System 6958922PT | 6958922PT | 00613994358097 | — | No longer on the market |
| VERTEX® Reconstruction System 6958944 | 6958944 | 00613994354419 | — | On the market |
| VERTEX® Reconstruction System 6958948 | 6958948 | 00613994354396 | — | On the market |
| VERTEX® Reconstruction System 7751116PT | 7751116PT | 00613994460011 | Length 16.0 mm; Outer Diameter 5.0 mm | No longer on the market |
| VERTEX® Reconstruction System 7751120EP | 7751120EP | 00613994459695 | Length 20.0 mm; Outer Diameter 5.0 mm | No longer on the market |
| VERTEX® Reconstruction System 7751132PT | 7751132PT | 00613994459886 | Length 32.0 mm; Outer Diameter 5.0 mm | No longer on the market |
| VERTEX® Reconstruction System 7751134PT | 7751134PT | 00613994459879 | Outer Diameter 5.0 mm; Length 34.0 mm | No longer on the market |
| VERTEX® Reconstruction System 7751142EP | 7751142EP | 00613994460271 | Length 42.0 mm; Outer Diameter 5.0 mm | No longer on the market |
| VERTEX® Reconstruction System 7751146PT | 7751146PT | 00613994459817 | Outer Diameter 5.0 mm; Length 46.0 mm | No longer on the market |
| VERTEX® Reconstruction System 7751718PT | 7751718PT | 00613994459169 | Length 18.0 mm; Outer Diameter 3.5 mm | No longer on the market |
| VERTEX® Reconstruction System 7751720 | 7751720 | 00613994460912 | Length 20.0 mm; Outer Diameter 3.5 mm | On the market |
| VERTEX® Reconstruction System 7751722EP | 7751722EP | 00613994461636 | Length 22.0 mm; Outer Diameter 3.5 mm | On the market |
| VERTEX® Reconstruction System 7751724PT | 7751724PT | 00613994459145 | Outer Diameter 3.5 mm; Length 24.0 mm | On the market |
| VERTEX® Reconstruction System 7751726 | 7751726 | 00613994460882 | Outer Diameter 3.5 mm; Length 26.0 mm | On the market |
| VERTEX® Reconstruction System 7751732EP | 7751732EP | 00613994461261 | Length 32.0 mm; Outer Diameter 3.5 mm | No longer on the market |
| VERTEX® Reconstruction System 7751736PT | 7751736PT | 00613994459435 | Outer Diameter 3.5 mm; Length 36.0 mm | No longer on the market |
| VERTEX® Reconstruction System 7751744EP | 7751744EP | 00613994461209 | Length 44.0 mm; Outer Diameter 3.5 mm | No longer on the market |
| VERTEX® Reconstruction System 7751822EP | 7751822EP | 00613994461414 | — | On the market |
| VERTEX® Reconstruction System 7751824PT | 7751824PT | 00613994460301 | — | On the market |
| VERTEX® Reconstruction System 7751828EP | 7751828EP | 00613994461384 | — | On the market |
| VERTEX® Reconstruction System 7751834EP | 7751834EP | 00613994461353 | Length 34.0 mm; Outer Diameter 4.0 mm | On the market |
| VERTEX® Reconstruction System 7751842EP | 7751842EP | 00613994461315 | Outer Diameter 4.0 mm; Length 42.0 mm | No longer on the market |
| VERTEX® Reconstruction System 7751848EP | 7751848EP | 00613994461285 | Length 48.0 mm; Outer Diameter 4.0 mm | No longer on the market |
| VERTEX® Reconstruction System 7751852 | 7751852 | 00613994460547 | Length 52.0 mm; Outer Diameter 4.0 mm | No longer on the market |
| VERTEX® Reconstruction System 7751910EP | 7751910EP | 00613994459619 | Outer Diameter 4.5 mm; Length 10.0 mm | No longer on the market |
| VERTEX® Reconstruction System 7751924PT | 7751924PT | 00613994460431 | Outer Diameter 4.5 mm; Length 24.0 mm | No longer on the market |
| VERTEX® Reconstruction System 7751942EP | 7751942EP | 00613994459480 | Outer Diameter 4.5 mm; Length 42.0 mm | No longer on the market |
| VERTEX® Reconstruction System 7751946PT | 7751946PT | 00613994460325 | Outer Diameter 4.5 mm; Length 46.0 mm | No longer on the market |
| VERTEX® Reconstruction System 7751952 | 7751952 | 00613994460646 | Length 52.0 mm; Outer Diameter 4.5 mm | No longer on the market |
| VERTEX® Reconstruction System X0412221 | X0412221 | 00643169176737 | Length 12.0 mm | On the market |
| VERTEX® Reconstruction System X0412225 | X0412225 | 00643169176690 | Length 20.0 mm | On the market |
| VERTEX® Reconstruction System X0412227 | X0412227 | 00643169176676 | Length 24.0 mm | On the market |
| VERTEX® Reconstruction System X0412228 | X0412228 | 00643169176669 | Length 26.0 mm | On the market |
| VERTEX® Reconstruction System X0811243 | X0811243 | 00643169080652 | Length 24.0 mm | No longer on the market |
| VERTEX® Reconstruction System X0811246 | X0811246 | 00643169080683 | Length 30.0 mm | On the market |
| VERTEX® Reconstruction System X0811251 | X0811251 | 00643169080737 | Length 40.0 mm | On the market |
| VERTEX® Reconstruction System X0811253 | X0811253 | 00643169080751 | Length 44.0 mm | On the market |
| VERTEX® Reconstruction System X0811264 | X0811264 | 00643169080867 | Length 36.0 mm | On the market |
| VERTEX® Reconstruction System X0811280 | X0811280 | 00643169080560 | Length 38.0 mm | On the market |
| VERTEX® Reconstruction System X0811281 | X0811281 | 00643169080577 | Length 40.0 mm | On the market |
| VERTEX® Reconstruction System X0811282 | X0811282 | 00643169080584 | Length 42.0 mm | On the market |
| VERTEX® Reconstruction System X0811283 | X0811283 | 00643169080591 | Length 44.0 mm | On the market |
| VERTEX® Reconstruction System X1108073 | X1108073 | 00613994597601 | — | On the market |
| VERTEX® Reconstruction System X1211113 | X1211113 | 00643169115088 | — | On the market |
| VERTEX® Reconstruction System X1211123 | X1211123 | 00643169114708 | — | On the market |
| VERTEX® Reconstruction System X1211133 | X1211133 | 00643169114883 | — | On the market |
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