The following data is part of a premarket notification filed by Osteomedics, Inc. with the FDA for Normed Titanium Osteotomy Plating System.
| Device ID | K022325 |
| 510k Number | K022325 |
| Device Name: | NORMED TITANIUM OSTEOTOMY PLATING SYSTEM |
| Classification | Plate, Fixation, 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 | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-07-17 |
| Decision Date | 2002-09-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840420136800 | K022325 | 000 |
| 00840420136411 | K022325 | 000 |
| 00840420136398 | K022325 | 000 |
| 00840420136381 | K022325 | 000 |
| 00840420136343 | K022325 | 000 |
| 00840420136145 | K022325 | 000 |
| 00840420136107 | K022325 | 000 |
| 00840420136039 | K022325 | 000 |
| 00840420136008 | K022325 | 000 |
| 00840420135995 | K022325 | 000 |
| 00840420136459 | K022325 | 000 |
| 00840420136510 | K022325 | 000 |
| 00840420136763 | K022325 | 000 |
| 00840420136732 | K022325 | 000 |
| 00840420136718 | K022325 | 000 |
| 00840420136701 | K022325 | 000 |
| 00840420136695 | K022325 | 000 |
| 00840420136688 | K022325 | 000 |
| 00840420136671 | K022325 | 000 |
| 00840420136664 | K022325 | 000 |
| 00840420136626 | K022325 | 000 |
| 00840420135988 | K022325 | 000 |