STS SCREW

Screw, Fixation, Bone

ORTHO-PRO LLC

The following data is part of a premarket notification filed by Ortho-pro Llc with the FDA for Sts Screw.

Pre-market Notification Details

Device IDK032682
510k NumberK032682
Device Name:STS SCREW
ClassificationScrew, Fixation, Bone
Applicant ORTHO-PRO LLC 1001 OAKWOOD BLVD Round Rock,  TX  78681
ContactJ.d. Webb
CorrespondentJ.d. Webb
ORTHO-PRO LLC 1001 OAKWOOD BLVD Round Rock,  TX  78681
Product CodeHWC  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-08-29
Decision Date2003-10-22
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00840420169518 K032682 000
00840420169501 K032682 000
00840420169495 K032682 000
00840420169488 K032682 000
00840420169471 K032682 000
00840420169426 K032682 000
00840420169419 K032682 000
00840420169402 K032682 000

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