The following data is part of a premarket notification filed by Phoenix Bioengineering, Inc. with the FDA for Phoenix Bone Screws Pbs-type Series.
| Device ID | K930125 |
| 510k Number | K930125 |
| Device Name: | PHOENIX BONE SCREWS PBS-TYPE SERIES |
| Classification | Prosthesis, Tendon, Passive |
| Applicant | PHOENIX BIOENGINEERING, INC. THIRD AND MILL STREETS P.O. BOX 96 Bridgeport, PA 19405 |
| Contact | Horace J Wilmer |
| Correspondent | Horace J Wilmer PHOENIX BIOENGINEERING, INC. THIRD AND MILL STREETS P.O. BOX 96 Bridgeport, PA 19405 |
| Product Code | HXA |
| CFR Regulation Number | 888.3025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-01-12 |
| Decision Date | 1993-12-30 |