METAL HEMI IMPLANT

Prosthesis, Toe, Hemi-, Phalangeal

ORTHOPRO LLC

The following data is part of a premarket notification filed by Orthopro Llc with the FDA for Metal Hemi Implant.

Pre-market Notification Details

Device IDK071243
510k NumberK071243
Device Name:METAL HEMI IMPLANT
ClassificationProsthesis, Toe, Hemi-, Phalangeal
Applicant ORTHOPRO LLC 1001 OAKWOOD BLVD. Round Rock,  TX  78681
ContactJ.d. Webb
CorrespondentJ.d. Webb
ORTHOPRO LLC 1001 OAKWOOD BLVD. Round Rock,  TX  78681
Product CodeKWD  
CFR Regulation Number888.3730 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-05-03
Decision Date2007-05-23
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00840420168337 K071243 000
00840420168320 K071243 000
00840420168313 K071243 000
00840420168306 K071243 000

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