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 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 25, 1998 | K981275 | SYNTHES (USA) RATCHETING DISTRACTOR Synthes (Usa) | MQN |
| Jun 22, 1998 | K981075 | SYNTHES (USA) (SYNTHES) SINGLE VECTOR DISTRACTOR WITH DETACHABLE FEET Synthes (Usa) | MQN |
| Nov 20, 1997 | K973275 | KLS-MARTIN INTRAORAL DISTRACTOR KLS-Martin L.P. | MQN |
| Nov 10, 1997 | K973018 | SYNTHES MINI LENGTHENING APPARATUS Synthes (Usa) | MQN |
| Jun 24, 1997 | K972047 | KLS-MARTIN RIGID EXTERNAL DISTRACTION DEVICE KLS-Martin L.P. | MQN |
| Aug 30, 1996 | K962272 | SYNTHES MANDIBLE DISTRACTOR Synthes (Usa) | MQN |
| Aug 6, 1996 | K960297 | MANDIBULAR BONE DISTRACTOR II Howmedica Corp. | MQN |
| Feb 14, 1996 | K955640 | LORENZ MANDIBULAR DISTRACTOR Biomet, Inc. | MQN |
| Feb 6, 1996 | K952847 | NORMED BIDIRECTRIONAL/MULTIDIRECTIONAL JAW DISTRACTOR Ace Surgical Supply Co., Inc. | MQN |
| Jun 2, 1995 | K945674 | MANDIBULAR BONE DISTRACTOR Howmedica Corp., ES | MQN |
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