510(k) K121392 ยท LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
NOVATION CROWN CUP LINERS; NEUTRAL, LIPPED, +5MM LATERALIZED, +5/10 DEGREE
| Applicant | Exactech, Inc., Gainesville FL, US |
| Decision | Substantially Equivalent, Jan 16, 2013 |
| Received | May 9, 2012 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K121392
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 11, 2022 | Exactech, Inc. GXL acetabular liners, orthopedic hip implant component. Product Line Numbers:
a. NOVATION GXL LINER NEUTRAL, 32MM ID GROUP 1 CUPS, REF 130-32-51
b. NOVATION GXL LINER NEUTRAL, 36MM ID, GROUP 2 CU Open, Classified |
LZO | None listed |
| Jul 22, 2021 | Exactech, Inc. Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-32-XX, Acumatch GXL 0 Degree Liner, 32mm; and Novation GXL Liner, Neutral, 32mm. Orthopedic hi Open, Classified |
LPH | None listed |
| Jul 22, 2021 | Exactech, Inc. Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-36-XX, Acumatch GXL 0 Degree Liner, 36mm; and Novation GXL Liner, Neutral, 36mm. Orthopedic hi Open, Classified |
LPH | None listed |
| Jul 22, 2021 | Exactech, Inc. Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-40-XX, Novation GXL Liner, Neutral, 40mm. Orthopedic hip implant component. Open, Classified |
LPH | None listed |
| Jul 22, 2021 | Exactech, Inc. Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-40-XX, Novation GXL Liner, Lipped Ant, 40mm; Novation GXL Liner, Lipped, 40mm. Orthopedic hip Open, Classified |
LPH | None listed |
| Jul 22, 2021 | Exactech, Inc. Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 136-40-XX, Novation GXL Liner, +5mm Lateralized, 40mm. Orthopedic hip implant component. Open, Classified |
LZO | None listed |
| Jul 22, 2021 | Exactech, Inc. Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-32-XX, Acumatch GXL 15 Degree Liner, 32mm; Novation GXL Liner, Lipped Ant, 32mm; and Novation G Open, Classified |
LPH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.