PHOENIX BONE SCREWS PBS-TYPE SERIES

Prosthesis, Tendon, Passive

PHOENIX BIOENGINEERING, INC.

The following data is part of a premarket notification filed by Phoenix Bioengineering, Inc. with the FDA for Phoenix Bone Screws Pbs-type Series.

Pre-market Notification Details

Device IDK930125
510k NumberK930125
Device Name:PHOENIX BONE SCREWS PBS-TYPE SERIES
ClassificationProsthesis, Tendon, Passive
Applicant PHOENIX BIOENGINEERING, INC. THIRD AND MILL STREETS P.O. BOX 96 Bridgeport,  PA  19405
ContactHorace J Wilmer
CorrespondentHorace J Wilmer
PHOENIX BIOENGINEERING, INC. THIRD AND MILL STREETS P.O. BOX 96 Bridgeport,  PA  19405
Product CodeHXA  
CFR Regulation Number888.3025 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-01-12
Decision Date1993-12-30

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