510(k) K173331 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
JOURNEY II XR Knee Instruments
| Applicant | Smith & Nephew, Inc., Memphis TN, US |
| Decision | Substantially Equivalent, Nov 16, 2017 |
| Received | Oct 23, 2017 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K173331
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 10, 2018 | Smith & Nephew, Inc. JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 1-2 , REF 74013986
The JOURNEY II XR Tibial Posterior Keel Punch is a reusable surgical instrument used to prepare the proximal tibial to receive a JOURNE Terminated |
JWH | None listed |
| Dec 10, 2018 | Smith & Nephew, Inc. JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 3-4 , REF 74013987
The JOURNEY II XR Tibial Posterior Keel Punch is a reusable surgical instrument used to prepare the proximal tibial to receive a JOURNE Terminated |
JWH | None listed |
| Dec 10, 2018 | Smith & Nephew, Inc. JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 5-6 , REF 74013988
The JOURNEY II XR Tibial Posterior Keel Punch is a reusable surgical instrument used to prepare the proximal tibial to receive a JOURNE Terminated |
JWH | None listed |
| Dec 10, 2018 | Smith & Nephew, Inc. JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 7-8 , REF 74013988
The JOURNEY II XR Tibial Posterior Keel Punch is a reusable surgical instrument used to prepare the proximal tibial to receive a JOURNE Terminated |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.