510(k) K133827 ยท OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
A-LINK Z
| Applicant | Osteo Vasive, LLC, San Diego CA, US |
| Decision | Substantially Equivalent, Nov 17, 2014 |
| Received | Dec 17, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K133827
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 7, 2019 | Acuity Surgical Devices, LLC A LINK Z INTERVERTEBRAL BODY FUSION DEVICE
Product Description:
A Link Z Ti Unitary Plate-Cage 32x21x15 7
A Link Z Ti Unitary Plate-Cage 32x21x15 12
A Link Z Ti Unitary Plate-Cage 32x21x15 16
A Link Open, Classified |
OVD | None listed |
| Jan 7, 2019 | Acuity Surgical Devices, LLC A LINK Z INTERVERTEBRAL BODY FUSION DEVICE
Product Description:
A Link Z Ti Unitary Open Interbody 32x24x12 7
A Link Z Ti Unitary Open Interbody 32x24x12 12
A Link Z Ti Unitary Open Interbody 32x24x1 Open, Classified |
OVD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.