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 |