SYNTHES (USA) EXTERNAL MULTI VECTOR MANDIBLE DISTRACTOR

Screw, Fixation, Intraosseous

SYNTHES (USA)

The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (usa) External Multi Vector Mandible Distractor.

Pre-market Notification Details

Device IDK981362
510k NumberK981362
Device Name:SYNTHES (USA) EXTERNAL MULTI VECTOR MANDIBLE DISTRACTOR
ClassificationScrew, Fixation, Intraosseous
Applicant SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli,  PA  19301 -1222
ContactSheri L Musgnung
CorrespondentSheri L Musgnung
SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli,  PA  19301 -1222
Product CodeDZL  
CFR Regulation Number872.4880 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-04-15
Decision Date1998-06-29
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20887587029693 K981362 000
10887587055497 K981362 000
10887587055510 K981362 000
10887587055534 K981362 000
10887587055558 K981362 000
10887587055572 K981362 000
10887587055596 K981362 000
10887587055619 K981362 000
10887587055848 K981362 000
10887587055855 K981362 000
10887587055862 K981362 000
10887587055879 K981362 000
H9803955750 K981362 000

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