PBP TOTAL HIP SYSTEM


Device Classification Name

hip prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented

510(k) Number K122158
Device Name PBP TOTAL HIP SYSTEM
Applicant
PIPELINE BIOMEDICAL PRODUCTS, LLC
901 king street
suite 200
alexandria, 
VA 
22314

Applicant Contact terry powell
Correspondent
PIPELINE BIOMEDICAL PRODUCTS, LLC
901 king street
suite 200
alexandria, 
VA 
22314

Correspodent Contact terry powell
Regulation Number 888.3358
Classification Product Code
OQG  
Subsequent Product Codes
JDI   LPH   LZO   MEH   OQH  
OQI  
Date Received 07/20/2012
Decision Date 12/11/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No