SMITH & NEPHEW PATELLO-FEMORAL IMPLANT

Prosthesis, Knee, Patello/femoral, Semi-constrained, Cemented, Metal/polymer

SMITH & NEPHEW, INC.

The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Smith & Nephew Patello-femoral Implant.

Pre-market Notification Details

Device IDK051086
510k NumberK051086
Device Name:SMITH & NEPHEW PATELLO-FEMORAL IMPLANT
ClassificationProsthesis, Knee, Patello/femoral, Semi-constrained, Cemented, Metal/polymer
Applicant SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis,  TN  38116
ContactGino Rouss
CorrespondentGino Rouss
SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis,  TN  38116
Product CodeKRR  
CFR Regulation Number888.3540 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-04-28
Decision Date2005-05-31
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
03596010573315 K051086 000
03596010573308 K051086 000
03596010544247 K051086 000
03596010544230 K051086 000
03596010544223 K051086 000
03596010544216 K051086 000
03596010544209 K051086 000
03596010544193 K051086 000

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