510(k) K060988 ยท KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
TOTAL AND HEMI SHOULDER SYSTEM
| Applicant | Dvo Extremity Solutions, LLC, Derby CT, US |
| Decision | Substantially Equivalent, Dec 6, 2006 |
| Received | Apr 10, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K060988
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 23, 2009 | Tournier, Inc. Tornier AFFINITI Humeral Stem Standard 10mm, Catalog No. 0020010. Sterile. Manufactured for Tornier, 10750 Cash Rd., Stafford, TX 77477. Tornier's Affiniti Shoulder System is a non-constrained g Terminated |
KWS | None listed |
| Jan 23, 2009 | Tournier, Inc. Tornier AFFINITI Humeral Stem Standard 14mm, Catalog No. 0020014. Sterile. Manufactured for Tornier, 10750 Cash Rd., Stafford, TX 77477. Tornier's Affiniti Shoulder System is a non-constrained g Terminated |
KWS | None listed |
| Jan 23, 2009 | Tournier, Inc. Tornier AFFINITI Humeral Head Eccentric 44mm x 18mm, Catalog No. 0020025. Sterile. Manufactured for Tornier, 10750 Cash Rd., Stafford, TX 77477. Tornier's Affiniti Shoulder System is a non-const Terminated |
KWS | None listed |
| Jan 23, 2009 | Tournier, Inc. Tornier AFFINITI Humeral Head Eccentric 44mm x 21mm, Catalog No. 0020026. Sterile. Manufactured for Tornier, 10750 Cash Rd., Stafford, TX 77477. Tornier's Affiniti Shoulder System is a non-const Terminated |
KWS | None listed |
| Jan 23, 2009 | Tournier, Inc. Tornier AFFINITI Humeral Head Eccentric 48mm x 21mm, Catalog No. 0020030. Sterile. Manufactured for Tornier, 10750 Cash Rd., Stafford, TX 77477. Tornier's Affiniti Shoulder System is a non-const Terminated |
KWS | None listed |
| Jan 23, 2009 | Tournier, Inc. Tornier AFFINITI Humeral Head Eccentric 52mm x 21mm, Catalog No. 0020034. Sterile. Manufactured for Tornier, 10750 Cash Rd., Stafford, TX 77477. Tornier's Affiniti Shoulder System is a non-const Terminated |
KWS | None listed |
| Jan 23, 2009 | Tournier, Inc. Tornier AFFINITI Humeral Head Eccentric 56mm x 21mm, Catalog No. 0020038. Sterile. Manufactured for Tornier, 10750 Cash Rd., Stafford, TX 77477. Tornier's Affiniti Shoulder System is a non-const Terminated |
KWS | None listed |
| Jan 23, 2009 | Tournier, Inc. Tornier AFFINITI Humeral Head Standard 44mm x 15mm, Catalog No. 0020044. Sterile. Manufactured for Tornier, 10750 Cash Rd., Stafford, TX 77477. Tornier's Affiniti Shoulder System is a non-constr Terminated |
KWS | None listed |
| Jan 23, 2009 | Tournier, Inc. Tornier AFFINITI Humeral Head Standard 44mm x 18mm, Catalog No. 0020045. Sterile. Manufactured for Tornier, 10750 Cash Rd., Stafford, TX 77477. Tornier's Affiniti Shoulder System is a non-constr Terminated |
KWS | None listed |
| Jan 23, 2009 | Tournier, Inc. Tornier AFFINITI Humeral Head Standard 44mm x 21mm, Catalog No. 0020046. Sterile. Manufactured for Tornier, 10750 Cash Rd., Stafford, TX 77477. Tornier's Affiniti Shoulder System is a non-constr Terminated |
KWS | None listed |
| Jan 23, 2009 | Tournier, Inc. Tornier AFFINITI Humeral Head Standard 48mm x 15mm, Catalog No. 0020048. Sterile. Manufactured for Tornier, 10750 Cash Rd., Stafford, TX 77477. Tornier's Affiniti Shoulder System is a non-constr Terminated |
KWS | None listed |
| Jan 23, 2009 | Tournier, Inc. Tornier AFFINITI Humeral Head Standard 48mm x 18mm, Catalog No. 0020049. Sterile. Manufactured for Tornier, 10750 Cash Rd., Stafford, TX 77477. Tornier's Affiniti Shoulder System is a non-constr Terminated |
KWS | None listed |
| Jan 23, 2009 | Tournier, Inc. Tornier AFFINITI Humeral Head Standard 48mm x 21mm, Catalog No. 0020050. Sterile. Manufactured for Tornier, 10750 Cash Rd., Stafford, TX 77477. Tornier's Affiniti Shoulder System is a non-constr Terminated |
KWS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.