510(k) K063578 ยท HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
PROMOS MODULAR SHOULDER SYSTEM
| Applicant | Plus Orthopedics AG, Norfolk MA, US |
| Decision | Substantially Equivalent, Mar 2, 2007 |
| Received | Nov 30, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K063578
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 7, 2010 | Smith & Nephew Inc PROMOS Inclination set, SIZE 20mm, REF 42 180, S&N 75006722, QTY: (1), STERILE R, Smith & Nephew Orthopaedics AG, CH-Rotkreuz-Switzerland.
The device is used as a semi-constrained, metal/polymer ceme Terminated |
KWS | None listed |
| Apr 7, 2010 | Smith & Nephew Inc PROMOS Inclination set, SIZE 22mm, REF 42 182, S&N 75006723, QTY: (1), STERILE R, Smith & Nephew Orthopaedics AG, CH-Rotkreuz-Switzerland.
The device is used as a semi-constrained, metal/polymer ceme Terminated |
KWS | None listed |
| Apr 7, 2010 | Smith & Nephew Inc PROMOS Inclination set, SIZE 24mm, REF 42 184, S&N 75006724, QTY: (1), STERILE R, Smith & Nephew Orthopaedics AG, CH-Rotkreuz-Switzerland.
The device is used as a semi-constrained, metal/polymer ceme Terminated |
KWS | None listed |
| Apr 7, 2010 | Smith & Nephew Inc PROMOS Inclination set, SIZE 26mm, REF 42 186, S&N 75006725, QTY: (1), STERILE R, Smith & Nephew Orthopaedics AG, CH-Rotkreuz-Switzerland.
The device is used as a semi-constrained, metal/polymer ceme Terminated |
KWS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.