The following data is part of a premarket notification filed by Orthopaedic Device Corp. with the FDA for Superfixation(tm).
| Device ID | K863343 |
| 510k Number | K863343 |
| Device Name: | SUPERFIXATION(TM) |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | ORTHOPAEDIC DEVICE CORP. 6 PEARL COURT Allendale, NJ 07401 |
| Contact | Alex Khowaylo |
| Correspondent | Alex Khowaylo ORTHOPAEDIC DEVICE CORP. 6 PEARL COURT Allendale, NJ 07401 |
| Product Code | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-08-29 |
| Decision Date | 1986-09-15 |