FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

CENTERING PLUG

K Number: K900392 · Decision Mar 1, 1990
Classifications
1
FEI Numbers
55
Registration Numbers
55
Same Product Code
36
Applicant Total
16
Review Days
34

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Basic Information

Device Name
CENTERING PLUG
K Number
K900392
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
878.3300
Medical Specialty
General, Plastic Surgery
Decision
Substantially Equivalent
Applicant
Allo Pro Corp.
Date Received
January 26, 1990
Decision Date
March 1, 1990
Product Code
LZN
Advisory Committee
General, Plastic Surgery
Review Advisory Committee
OR
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
LZN Cement Obturator

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K885049 RS-CUP ACETABULAR PROSTHESIS
K864999 KENNEDY STEM
K871453 ZWEYMUELLER-SL HIP PROSTHESIS STEM
K851213 ZWEYMULLER CUP
K841391 WEBER-STUHMER HIP PROSTHESIS STEM
K830948 WEBER/STIIHMER FEMORAL HEAD PROSTHESIS
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