510(k) K132505 ยท MAX Intervertebral Fusion Device With Bone Graft, Lumbar
ACCULIF TL AND PL CAGE
| Applicant | Coalign Innovations, Inc., Washington DC, US |
| Decision | Substantially Equivalent, Sep 12, 2013 |
| Received | Aug 12, 2013 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K132505
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 26, 2016 | Howmedica Osteonics Corp. AccuLIF PL 6-9mm x 11mm x 27mm x 8 Cage, Rx only, Sterile R, Legal The AccuLIF PL Cages are indicated for intervertebral body fusion with autograft and/or allogeneic bone graft comprised of cancellous Terminated |
MAX | None listed |
| Jul 26, 2016 | Howmedica Osteonics Corp. AccuLIF PL 8-12mm x 11mm x 27mm x 8 Cage, Rx only, Sterile R, Legal The AccuLIF PL Cages are indicated for intervertebral body fusion with autograft and/or allogeneic bone graft comprised of cancellou Terminated |
MAX | None listed |
| Jul 26, 2016 | Howmedica Osteonics Corp. AccuLIF PL 10-16mm x 11mm x 27mm x 8 Cage, Rx only, Sterile R, Legal The AccuLIF PL Cages are indicated for intervertebral body fusion with autograft and/or allogeneic bone graft comprised of cancello Terminated |
MAX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.