External Mandibular Fixator And/Or Distractor
Regulation 872.4760
0510(k)s in 12 months (60 all time)
0recalls in 12 months (9 all time)
9recalls that name a 510(k)
Top companies in MQN
| Company | 510(k)s | Recalls |
|---|---|---|
| Synthes (Usa) | 13 | 2 |
| KLS Martin L.P. | 13 | 0 |
| Synthes (USA) Products, LLC | 3 | 6 |
| Osteomed Corp. | 7 | 0 |
| Walter Lorenz Surgical, Inc. | 6 | 0 |
| Oral Osteodistraction, L.P. | 3 | 0 |
| Howmedica Corp. | 2 | 0 |
| Stryker | 2 | 0 |
| Ace Surgical Supply Co., Inc. | 1 | 0 |
| Biomet, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 | K981075 |
| 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 | K981075 |
| 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 | K981075 |
| 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 | K981075 |
| 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 | K981075 |
| 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 | K981075 |
| Jan 23, 2015 | Synthes, Inc. The Synthes Mandible External Fixator; all lots of part nos.:
04.305.003
04.305.004
04.305.005
04.305.010
04.305.011
04.305.012
03.305.006
04.305.100
04.305.101
04.305.102
04.305.103
04.305.128
04.3 Terminated |
MQN | K040169 K050378 |
| Aug 20, 2014 | Synthes, Inc. DePuy Synthes Craniomaxillofacial Distraction System (AB Distractor Bodies and BC Distractor Bodies) Terminated |
MQN | K060138 |
| Jul 12, 2013 | Synthes USA HQ, Inc. Synthes CMF Distraction System
The product is intended for use as a bone stabilizer and lengthening (and/or transport) device for correction of congenital deficiencies or post-traumatic defects of th Terminated |
MQN | K060138 |
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