The following data is part of a premarket notification filed by Osteomedics with the FDA for Normed Extremity Titanium Hand And Small Fragment System.
| Device ID | K011118 |
| 510k Number | K011118 |
| Device Name: | NORMED EXTREMITY TITANIUM HAND AND SMALL FRAGMENT SYSTEM |
| Classification | Plate, Fixation, Bone |
| Applicant | OSTEOMEDICS 809 CARTER LN. Paramus, NJ 07672 |
| Contact | Albert Enayati |
| Correspondent | Albert Enayati OSTEOMEDICS 809 CARTER LN. Paramus, NJ 07672 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-04-12 |
| Decision Date | 2001-07-20 |