The following data is part of a premarket notification filed by Osteomedics, Inc. with the FDA for Normed Bi-directional/multidirectional Jaw Distractor.
| Device ID | K021342 |
| 510k Number | K021342 |
| Device Name: | NORMED BI-DIRECTIONAL/MULTIDIRECTIONAL JAW DISTRACTOR |
| Classification | Plate, Bone |
| Applicant | OSTEOMEDICS, INC. 809 CARTER LN. Paramus, NJ 07652 |
| Contact | Albert Enayati |
| Correspondent | Albert Enayati OSTEOMEDICS, INC. 809 CARTER LN. Paramus, NJ 07652 |
| Product Code | JEY |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-04-29 |
| Decision Date | 2002-08-01 |
| Summary: | summary |