Company
Tournier, Inc.
FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.
0510(k) clearances (0 in 12 months)
18recalls (0 in 12 months)
13recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | 18 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 23, 2009 | Tournier, Inc. Tornier AFFINITI Humeral Head Standard 56mm x 21mm, Catalog No. 0020058. 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 56mm x 21mm, Catalog No. 0020057. 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 52mm x 21mm, Catalog No. 0020054. 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 52mm x 18mm, Catalog No. 0020053. 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 52mm x 15mm, Catalog No. 0020052. 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 | K060988 |
| 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 | K060988 |
| 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 | K060988 |
| 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 | K060988 |
| 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 | K060988 |
| 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 | K060988 |
| 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 | K060988 |
| 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 | K060988 |
| 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 | K060988 |
| 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 | K060988 |
| 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 | K060988 |
| 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 | K060988 |
| 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 | K060988 |