The following data is part of a premarket notification filed by Orthopaedic Biosystems, Ltd. with the FDA for Threaded Fixation Pin.
| Device ID | K963433 |
| 510k Number | K963433 |
| Device Name: | THREADED FIXATION PIN |
| Classification | Pin, Fixation, Threaded |
| Applicant | ORTHOPAEDIC BIOSYSTEMS, LTD. 7320 EAST BUTHERUS SUITE 206 Scotsdale, AZ 85260 |
| Contact | Jeffry B Skiba |
| Correspondent | Jeffry B Skiba ORTHOPAEDIC BIOSYSTEMS, LTD. 7320 EAST BUTHERUS SUITE 206 Scotsdale, AZ 85260 |
| Product Code | JDW |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-30 |
| Decision Date | 1996-11-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M209180320 | K963433 | 000 |
| M209175500 | K963433 | 000 |
| M209171490 | K963433 | 000 |