510(k) K140411 ยท MAX Intervertebral Fusion Device With Bone Graft, Lumbar
ALTERA SPACER
| Applicant | Globus Medical, Inc., Audubon PA, US |
| Decision | Substantially Equivalent, Jul 1, 2014 |
| Received | Feb 18, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K140411
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 22, 2020 | Globus Medical, Inc. ALTERA Spacer
ALTERA Spacer, 10x31, 8-12mm, 8 (sterile) Terminated |
MAX | None listed |
| Aug 22, 2020 | Globus Medical, Inc. ALTERA Spacer
ALTERA Spacer, 10x26, 8-12mm, 8 Terminated |
MAX | None listed |
| Aug 22, 2020 | Globus Medical, Inc. ALTERA Spacer
ALTERA Spacer, 10x26, 9-13mm, 8 Terminated |
MAX | None listed |
| Aug 22, 2020 | Globus Medical, Inc. ALTERA Spacer
ALTERA Spacer, 10x26, 10-14mm, 8 Terminated |
MAX | None listed |
| Aug 22, 2020 | Globus Medical, Inc. ALTERA Spacer
ALTERA Spacer, 10x26, 12-16mm, 8 Terminated |
MAX | None listed |
| Aug 22, 2020 | Globus Medical, Inc. ALTERA Spacer
ALTERA Spacer, 10x26, 9-13mm, 15 Terminated |
MAX | None listed |
| Aug 22, 2020 | Globus Medical, Inc. ALTERA Spacer
ALTERA Spacer, 10x26, 10-14mm, 15 Terminated |
MAX | None listed |
| Aug 22, 2020 | Globus Medical, Inc. ALTERA Spacer
ALTERA Spacer, 10x26, 12-16mm, 15 Terminated |
MAX | None listed |
| Aug 22, 2020 | Globus Medical, Inc. ALTERA Spacer
ALTERA Spacer, 10x31, 8-12mm, 8 Terminated |
MAX | None listed |
| Aug 22, 2020 | Globus Medical, Inc. ALTERA Spacer
ALTERA Spacer, 10x31, 9-13mm, 8 Terminated |
MAX | None listed |
| Aug 22, 2020 | Globus Medical, Inc. ALTERA Spacer
ALTERA Spacer, 10x31, 10-14mm, 8 Terminated |
MAX | None listed |
| Aug 22, 2020 | Globus Medical, Inc. ALTERA Spacer
ALTERA Spacer, 10x31, 12-16mm, 8 Terminated |
MAX | None listed |
| Aug 22, 2020 | Globus Medical, Inc. ALTERA Spacer
ALTERA Spacer, 10x31, 9-13mm, 15 Terminated |
MAX | None listed |
| Aug 22, 2020 | Globus Medical, Inc. ALTERA Spacer
ALTERA Spacer, 10x31, 10-14mm, 15 Terminated |
MAX | None listed |
| Aug 22, 2020 | Globus Medical, Inc. ALTERA Spacer
ALTERA Spacer, 10x31, 12-16mm, 15 Terminated |
MAX | None listed |
| Aug 22, 2020 | Globus Medical, Inc. ALTERA Spacer
ALTERA Spacer, 10x36, 8-12mm, 8 Terminated |
MAX | None listed |
| Aug 22, 2020 | Globus Medical, Inc. ALTERA Spacer
ALTERA Spacer, 10x36, 9-13mm, 8 Terminated |
MAX | None listed |
| Aug 22, 2020 | Globus Medical, Inc. ALTERA Spacer
ALTERA Spacer, 10x36, 10-14mm, 8 Terminated |
MAX | None listed |
| Aug 22, 2020 | Globus Medical, Inc. ALTERA Spacer
ALTERA Spacer, 10x36, 12-16mm, 8 Terminated |
MAX | None listed |
| Aug 22, 2020 | Globus Medical, Inc. ALTERA Spacer
ALTERA Spacer, 10x36, 9-13mm, 15 Terminated |
MAX | None listed |
| Aug 22, 2020 | Globus Medical, Inc. ALTERA Spacer
ALTERA Spacer, 10x36, 10-14mm, 15 Terminated |
MAX | None listed |
| Aug 22, 2020 | Globus Medical, Inc. ALTERA Spacer
ALTERA Spacer, 10x36, 12-16mm, 15 Terminated |
MAX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.