510(k) K201585 ยท OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Monterey AL Interbody System
| Applicant | Stryker Corporation, Allendale NJ, US |
| Decision | Substantially Equivalent, Aug 10, 2020 |
| Received | Jun 11, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K201585
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 31, 2025 | Stryker Spine Monterey AL Implant Inserter; 10/12mm; Catalog 48019100. Open, Classified |
OVD | None listed |
| Mar 31, 2025 | Stryker Spine Monterey AL Implant Inserter; 14/16mm; Catalog 48019120. Open, Classified |
OVD | None listed |
| Mar 31, 2025 | Stryker Spine Monterey AL Implant Inserter; 18/20mm; Catalog 48019130. Open, Classified |
OVD | None listed |
| Mar 31, 2025 | Stryker Spine Monterey AL Implant Inserter; 22mm; Catalog 48019140. Open, Classified |
OVD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.