510(k) K151881 ยท KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
X-Fix Line Additions
| Applicant | Vilex IN Tennessee, Inc., Mcminnville TN, US |
| Decision | Substantially Equivalent, Mar 24, 2016 |
| Received | Jul 9, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K151881
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 22, 2022 | OrthoPediatrics Corp Orthex Large Bone Shoulder Bolt, model no. AS-17 Open, Classified |
OSN | None listed |
| Jun 29, 2022 | OrthoPediatrics Corp Orthex External Fixation Wire Sharp Bayonet 1.8 x 400 mm
Model: K400-18BN Open, Classified |
KTT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.