510(k) K102885 ยท JEC Component, Traction, Invasive
HOFFMANN II EXTERNAL FIXATION SYSTEM LINE EXTENSION MODEL 4920-1-010, 4920-1-020, 4920-1-030, 4920-1-100, HOFFMANN II EX
| Applicant | Stryker Corp., Mahwah NJ, US |
| Decision | Substantially Equivalent, Jan 14, 2011 |
| Received | Sep 30, 2010 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K102885
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 21, 2019 | Stryker GmbH Stryker Pin To Rod Coupling External Fixation System Hoffmann II Compact - Pin To Rod Coupling 5/3-4mm
Catalog #: 4940-1-020 - Product Usage: Indications Distal radius fractures (intra and extra) Terminated |
JEC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.