510(k) K143616 ยท MAX Intervertebral Fusion Device With Bone Graft, Lumbar
AccuLIF TL and PL Cage
| Applicant | Stryker Corporation, Allendale NJ, US |
| Decision | Substantially Equivalent, Mar 5, 2015 |
| Received | Dec 19, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K143616
| 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 |
| Dec 16, 2015 | Stryker Spine AccuLIF PL Tubing Set and AccuLIF TL Tubing Set
AccuLIF is an interbody device system that uses hydraulic pressure to expand the implant in-situ. The purpose of the AccuLIF PL Tubing Set (cat#900301 Terminated |
MAX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.