STAPLE, FIXATION BONE; SCREW FIXATION BONE

Screw, Fixation, Bone

ROSEBURG SA

The following data is part of a premarket notification filed by Roseburg Sa with the FDA for Staple, Fixation Bone; Screw Fixation Bone.

Pre-market Notification Details

Device IDK931155
510k NumberK931155
Device Name:STAPLE, FIXATION BONE; SCREW FIXATION BONE
ClassificationScrew, Fixation, Bone
Applicant ROSEBURG SA 1054 31ST STREET, N.W. SUITE 120 CANAL SQUARE Washington,  DC  20007
ContactIsabelle Floccia
CorrespondentIsabelle Floccia
ROSEBURG SA 1054 31ST STREET, N.W. SUITE 120 CANAL SQUARE Washington,  DC  20007
Product CodeHWC  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-03-09
Decision Date1994-09-01

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00887868010651 K931155 000
00887868010644 K931155 000
00887868010637 K931155 000
00887868010620 K931155 000
00887868115714 K931155 000
00887868115707 K931155 000
00887868115691 K931155 000
00887868115684 K931155 000

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