510(k) K091694 ยท HWC Screw, Fixation, Bone
MODIFICATION TO:LATARJET CORTICAL SCREW SET, MODELS 523JT, 523J (36-48MM)
| Applicant | Tag Medical Products, Somerset MA, US |
| Decision | Substantially Equivalent, Jul 7, 2009 |
| Received | Jun 10, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K091694
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 12, 2017 | DePuy Mitek, Inc., a Johnson & Johnson Co. DePuy Mitek LATARJET EXPERIENCE-Combo Screw Driver
Product Code: 288211
Product Usage:
The Latarjet Cortical Screw set is intended to treat recurrent shoulder instability by supporting the antero Terminated |
HWC | None listed |
| May 12, 2017 | DePuy Mitek, Inc., a Johnson & Johnson Co. DePuy Mitek LATARJET EXPERIENCE Coracoid Drill
Product Code: 288201
Product Usage:
The Latarjet Cortical Screw set is intended to treat recurrent shoulder instability by supporting the anteroinferi Terminated |
HWC | None listed |
| May 12, 2017 | DePuy Mitek, Inc., a Johnson & Johnson Co. DePuy Mitek LATARJET EXPERIENCE Coracoid Top Hat Drill
Product Code: 288202
Product Usage:
The Latarjet Cortical Screw set is intended to treat recurrent shoulder instability by supporting the ante Terminated |
HWC | None listed |
| May 12, 2017 | DePuy Mitek, Inc., a Johnson & Johnson Co. DePuy Mitek LATARJET EXPERIENCE Top Hat Tap
Product Code: 288203
Product Usage:
The Latarjet Cortical Screw set is intended to treat recurrent shoulder instability by supporting the anteroinferior Terminated |
HWC | None listed |
| May 12, 2017 | DePuy Mitek, Inc., a Johnson & Johnson Co. DePuy Mitek LATARJET EXPERIENCE Extraction Driver
Product Code: 288216
Product Usage:
The Latarjet Cortical Screw set is intended to treat recurrent shoulder instability by supporting the anteroin Terminated |
HWC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.