ZTT I AND II ACETABULAR CUP OF THE S-ROM TOTAL HIP SYSTEM

Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented

JOINT MEDICAL PRODUCTS CORP.

The following data is part of a premarket notification filed by Joint Medical Products Corp. with the FDA for Ztt I And Ii Acetabular Cup Of The S-rom Total Hip System.

Pre-market Notification Details

Device IDK951000
510k NumberK951000
Device Name:ZTT I AND II ACETABULAR CUP OF THE S-ROM TOTAL HIP SYSTEM
ClassificationProsthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Applicant JOINT MEDICAL PRODUCTS CORP. 860 CANAL ST. Stamford,  CT  06902
ContactKevin J Crossen
CorrespondentKevin J Crossen
JOINT MEDICAL PRODUCTS CORP. 860 CANAL ST. Stamford,  CT  06902
Product CodeLPH  
CFR Regulation Number888.3358 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-03-03
Decision Date1995-04-14

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10603295175988 K951000 000
10603295170730 K951000 000
10603295170723 K951000 000
10603295170716 K951000 000
10603295170709 K951000 000
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10603295170679 K951000 000
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10603295170747 K951000 000
10603295170754 K951000 000
10603295170761 K951000 000
10603295175971 K951000 000
10603295175964 K951000 000
10603295175957 K951000 000
10603295175940 K951000 000
10603295175933 K951000 000
10603295175926 K951000 000
10603295175919 K951000 000
10603295175902 K951000 000
10603295170655 K951000 000

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