SYNTHES (USA) UNIV. SCREW FIXATION SYSTEM (TITANIUM)

Orthosis, Spondylolisthesis Spinal Fixation

SYNTHES (USA)

The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (usa) Univ. Screw Fixation System (titanium).

Pre-market Notification Details

Device IDK951794
510k NumberK951794
Device Name:SYNTHES (USA) UNIV. SCREW FIXATION SYSTEM (TITANIUM)
ClassificationOrthosis, Spondylolisthesis Spinal Fixation
Applicant SYNTHES (USA) 1690 RUSSELL RD. POST OFFICE BOX 1766 Paoli,  PA  19301
ContactDiane T Brown
CorrespondentDiane T Brown
SYNTHES (USA) 1690 RUSSELL RD. POST OFFICE BOX 1766 Paoli,  PA  19301
Product CodeMNH  
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent For Some Indications (SN)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-04-07
Decision Date1995-08-21

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