The following data is part of a premarket notification filed by Howmedica Corp. with the FDA for Mandibular Bone Distractor Ii.
| Device ID | K960297 |
| 510k Number | K960297 |
| Device Name: | MANDIBULAR BONE DISTRACTOR II |
| Classification | External Mandibular Fixator And/or Distractor |
| Applicant | HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford, NJ 07070 |
| Contact | Margaret F Crowe |
| Correspondent | Margaret F Crowe HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford, NJ 07070 |
| Product Code | MQN |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-01-22 |
| Decision Date | 1996-08-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04546540257703 | K960297 | 000 |
| 04546540257697 | K960297 | 000 |
| 04546540257680 | K960297 | 000 |
| 04546540257673 | K960297 | 000 |
| 34546540259074 | K960297 | 000 |
| 34546540259067 | K960297 | 000 |
| 34546540259050 | K960297 | 000 |
| 34546540259043 | K960297 | 000 |