510(k) K981075 ยท MQN External Mandibular Fixator And/Or Distractor
SYNTHES (USA) (SYNTHES) SINGLE VECTOR DISTRACTOR WITH DETACHABLE FEET
| Applicant | Synthes (Usa), Paoli PA, US |
| Decision | Substantially Equivalent, Jun 22, 1998 |
| Received | Mar 24, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K981075
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 23, 2016 | Synthes (USA) Products LLC TI Single Vector Distractor Body with Right Foot/20mm; Catalog ID 487.962
The Titanium Single Vector Distractor and Proximal Foot Plates are intended for mandibular bone lengthening where gradual bon Terminated |
MQN | None listed |
| May 23, 2016 | Synthes (USA) Products LLC TI Single Vector Distractor Body with Left Foot/20mm; Catalog ID 487.963
The Titanium Single Vector Distractor and Proximal Foot Plates are intended for mandibular bone lengthening where gradual bone Terminated |
MQN | None listed |
| May 23, 2016 | Synthes (USA) Products LLC TI Single Vector Distractor Body with Right Foot/30mm; Catalog ID 487.964
The Titanium Single Vector Distractor and Proximal Foot Plates are intended for mandibular bone lengthening where gradual bon Terminated |
MQN | None listed |
| May 23, 2016 | Synthes (USA) Products LLC TI Single Vector Distractor Body with Left Foot/30mm; Catalog ID 487.965
The Titanium Single Vector Distractor and Proximal Foot Plates are intended for mandibular bone lengthening where gradual bone Terminated |
MQN | None listed |
| May 23, 2016 | Synthes (USA) Products LLC TI Single Vector Distractor Proximal Foot/Right; Catalog ID 487.974
The Titanium Single Vector Distractor and Proximal Foot Plates are intended for mandibular bone lengthening where gradual bone dist Terminated |
MQN | None listed |
| May 23, 2016 | Synthes (USA) Products LLC TI Single Vector Distractor Proximal Foot/Left; Catalog ID 487.975
The Titanium Single Vector Distractor and Proximal Foot Plates are intended for mandibular bone lengthening where gradual bone distr Terminated |
MQN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.