510(k) K071107 ยท MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM; NEX GEN COMPLETE KNEE SOLUTION CR-FLEX GENDER SOLUTIONS FEMALE FEMORAL COMPON
| Applicant | Zimmer, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Jul 6, 2007 |
| Received | Apr 19, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K071107
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 29, 2017 | Zimmer Biomet, Inc. CR-FLEX GSF PCT SZ C-R MINUS
CR-FLEX GSF PCT SZ D-L MINUS
CR-FLEX GSF PCT SZ D-R MINUS
CR-FLEX GSF PCT SZ E-L MINUS
CR-FLEX GSF PCT SZ E-R MINUS
CR-FLEX GSF PCT SZ F-L MINUS
CR-FLEX GSF PCT SZ F-R MIN Terminated |
JWH | None listed |
| Nov 29, 2017 | Zimmer Biomet, Inc. CR-FLEX GSF PRECOAT SZ C-L
CR-FLEX GSF PRECOAT SZ C-R
CR-FLEX GSF PRECOAT SZ D-L
CR-FLEX GSF PRECOAT SZ D-R
CR-FLEX GSF PRECOAT SZ E-L
CR-FLEX GSF PRECOAT SZ E-R
CR-FLEX GSF PRECOAT SZ F-L
CR-FLEX GSF Terminated |
JWH | None listed |
| Nov 29, 2017 | Zimmer Biomet, Inc. GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM GENDER SOLUTIONS FEMALE (GSF) FEMORAL COMPONENT NONPOROUS
N-K FLX GSF NP FEM SZ 0 RT
N-K FLX GSF NP FEM SZ 4 LT
N-K FLX GSF NP FEM SZ 4 RT
Compone Terminated |
JWH | None listed |
| Nov 29, 2017 | Zimmer Biomet, Inc. GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM FEMORAL COMPONENT
N-K FLX GSM POR FEM SZ 2 RT
N-K FLX GSM POR FEM SZ 3 LT
N-K FLX GSM POR FEM SZ 4 LT
N-K FLX GSM POR FEM SZ 4 RT
N-K FLX GSM POR Terminated |
MBH | None listed |
| Feb 22, 2016 | Zimmer Biomet, Inc. CR Flex GSF Precoat Fem
Natural Knee GSF NP Flex
Natural Knee GSF POR Flex
Natural Knee GSM NP Flex
Natural Knee GSM POR Flex
prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer Terminated |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.