510(k) K141821 ยท LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
ALTEON NECK PRESERVING FEMORAL STEM, STANDARD OFFSET, SIZE 6-7; ALTEON NECK PRESERVING FEMORAL STEM, EXTENDED OFFSET
| Applicant | Exactech, Inc., Gainesville FL, US |
| Decision | Substantially Equivalent, Aug 28, 2014 |
| Received | Jul 7, 2014 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K141821
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 7, 2016 | Exactech, Inc. Alteon Neck Preserving Stem, Standard Offset, Plasma Coated, Size 6 Terminated |
LZO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.