SYNTHES (USA) UNIV SPINE ROD/SACRAL SCREW FIX SYST

Appliance, Fixation, Spinal Interlaminal

SYNTHES (USA)

The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (usa) Univ Spine Rod/sacral Screw Fix Syst.

Pre-market Notification Details

Device IDK930891
510k NumberK930891
Device Name:SYNTHES (USA) UNIV SPINE ROD/SACRAL SCREW FIX SYST
ClassificationAppliance, Fixation, Spinal Interlaminal
Applicant SYNTHES (USA) 1690 RUSSELL RD. POST OFFICE BOX 1766 Paoli,  PA  19301
ContactDiane C Tiernan
CorrespondentDiane C Tiernan
SYNTHES (USA) 1690 RUSSELL RD. POST OFFICE BOX 1766 Paoli,  PA  19301
Product CodeKWP  
CFR Regulation Number888.3050 [🔎]
DecisionSubstantially Equivalent For Some Indications (SN)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-02-22
Decision Date1994-04-29

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
H9814985250 K930891 000

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