MANDIBULAR BONE DISTRACTOR
FDA 510(k) clearance K945674 · decided 1995-06-02
Clearance details
- K-number
- K945674
- Device name
- MANDIBULAR BONE DISTRACTOR
- Applicant
- Howmedica Corp.
- Decision
- Substantially Equivalent
- Date received
- 1994-11-18
- Decision date
- 1995-06-02
- Days to decision
- 196 days
- Clearance type
- Traditional
- Product code
- MQN
- Device class
- 2
- Regulation number
- 872.4760
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Madrid, ES
- Third-party review
- No
- Expedited review
- No
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Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| KLS Martin IPS Distraction (K220050) | KLS Martin L.P. | 2022-08-11 |
| DePuy Synthes Maxillofacial Portfolio - MR Conditional (K183113) | Synthes (USA) Products, LLC | 2019-03-13 |
| Stryker Pediatric Mandibular Distractor 2 (K181504) | Stryker | 2018-09-11 |
| Craniomaxillofacial Distraction System (CMFD) (K162594) | Synthes USA Products, LLC | 2017-05-08 |
| Internal Distraction - Sterile (K161470) | KLS Martin L.P. | 2016-12-01 |
| Mandible External Fixator - MR Conditional (K143285) | Synthes USA Products, LLC | 2015-05-28 |
| STRYKER PEDIATRIC MANDIBLE DISTRACTOR (K133398) | Stryker | 2014-03-20 |
| SYNTHES CURVILINEAR DISTRACTION SYSTEM (K121502) | Synthes, Inc. | 2012-08-23 |
| MIS CREST WIDENER (K080458) | Mis - Implant Technologies , Ltd. | 2008-12-17 |
| DISTRAX (K080542) | John W. King | 2008-12-15 |
| SYNTHES (USA) CURVILINEAR DISTRACTION SYSTEM (K080153) | Synthes (Usa) | 2008-05-14 |
| KLS MARTIN XTERNAL FIXATOR (K072764) | KLS Martin L.P. | 2007-12-20 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| SURGICAL SIMPLEX P BONE CEMENT (N17004/S013) | Howmedica Corp. | 2000-12-15 |
| SURGICAL SIMPLEX P RADIOPAQUE BONE CEMENT (N17004/S012) | Howmedica Corp. | 2000-06-20 |
| SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S011) | Howmedica Corp. | 1998-03-18 |
| SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S010) | Howmedica Corp. | 1997-11-13 |
| SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S009) | Howmedica Corp. | 1997-08-08 |
| SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S008) | Howmedica Corp. | 1996-12-18 |
| SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S005) | Howmedica Corp. | 1995-11-21 |
| SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S006) | Howmedica Corp. | 1995-02-24 |