510(k) K081620 ยท KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
MODIFICATION TO DEPUY DELTA XTEND REVERSE SHOULDER SYSTEM
| Applicant | DePuy Orthopaedics, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Jun 30, 2008 |
| Received | Jun 9, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K081620
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 15, 2009 | Depuy Orthopaedics, Inc. Depuy DELTA Xtend, Standard humeral PE Cup Dia 38/+3 STD, sterile, Depuy France; REF 130738203.
The device is used as a shoulder implant. Terminated |
KWS | None listed |
| Jan 15, 2009 | Depuy Orthopaedics, Inc. Depuy DELTA Xtend, Standard Humerus PE Cup, Dia 38/+6 STD, sterile, Depuy France; REF 130738206.
The device is used as a shoulder implant. Terminated |
KWS | None listed |
| Jan 15, 2009 | Depuy Orthopaedics, Inc. Depuy DELTA Xtend, Standard Humeral PE Cup, Dia 38/+9 STD, sterile, Depuy France; REF 130738209.
The device is used as a shoulder implant. Terminated |
KWS | None listed |
| Jan 15, 2009 | Depuy Orthopaedics, Inc. Depuy DELTA Xtend, Standard Humeral PE Cup, Dia 38/+6R RET, sterile, Depuy France; REF 130738106.
The device is used as a shoulder implant. Terminated |
KWS | None listed |
| Jan 15, 2009 | Depuy Orthopaedics, Inc. Depuy DELTA Xtend, Standard Humeral PE Cup, Dia 42/+3 STD, sterile, Depuy France; REF 130742203.
The device is used as a shoulder implant. Terminated |
KWS | None listed |
| Jan 15, 2009 | Depuy Orthopaedics, Inc. Depuy DELTA Xtend, Standard Humeral PE Cup, Dia 42/+6 STD, sterile, Depuy France; REF 130742206.
The device is used as a shoulder implant. Terminated |
KWS | None listed |
| Jan 15, 2009 | Depuy Orthopaedics, Inc. Depuy DELTA Xtend, Standard Humeral PE Cup, Dia 42/+9 STD, sterile, Depuy France; REF 130742209.
The device is used as a shoulder implant. Terminated |
KWS | None listed |
| Jan 15, 2009 | Depuy Orthopaedics, Inc. Depuy DELTA Xtend, Standard Humeral PE Cup, Dia 42+6R RET, sterile, Depuy France; REF 130742106.
The device is used as a shoulder implant. Terminated |
KWS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.