510(k) K031034 ยท GXN Plate, Cranioplasty, Preformed, Non-Alterable
SPIN DOWN RAPIDFLAP
| Applicant | Walter Lorenz Surgical, Inc., Jacksonville FL, US |
| Decision | Substantially Equivalent, May 21, 2003 |
| Received | Apr 1, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K031034
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 22, 2018 | Zimmer Biomet, Inc. Biomet Microfixation RapidFlap System 12mm SpinDown Clamp, sterile
Ref Number: 75-1020 Used for the re-attachment of the bone flap after a craniotomy. Terminated |
GXN | None listed |
| Aug 22, 2018 | Zimmer Biomet, Inc. Biomet Microfixation RapidFlap System, 12MM RapidFlap SpinDown Clamp, 12 Pack
Ref Number: 75-1020-12 Used for the re-attachment of the bone flap after a craniotomy. Terminated |
GXN | None listed |
| Aug 22, 2018 | Zimmer Biomet, Inc. Biomet Microfixation RapidFlap System 16MM RapidFlap SpinDown Clamp
Ref Number: 75-1030 Used for the re-attachment of the bone flap after a craniotomy. Terminated |
GXN | None listed |
| Aug 22, 2018 | Zimmer Biomet, Inc. Biomet Microfixation RapidFlap System
16MM RapidFlap SpinDown Clamp, 12 Pack
Ref Number: 75-1030-12 Used for the re-attachment of the bone flap after a craniotomy. Terminated |
GXN | None listed |
| Aug 22, 2018 | Zimmer Biomet, Inc. Biomet Microfixation RapidFlap System
20MM RapidFlap SpinDown Clamp
Ref Number: 75-1040 Used for the re-attachment of the bone flap after a craniotomy. Terminated |
GXN | None listed |
| Aug 22, 2018 | Zimmer Biomet, Inc. Biomet Microfixation RapidFlap System
20MM RapidFlap SpinDown Clamp, 12 Pack
Ref Number: 75-1040-12 Used for the re-attachment of the bone flap after a craniotomy. Terminated |
GXN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.