SYNTHES SPIRAL BLADE FOR HUMERAL NAIL (SBHN)

Nail, Fixation, Bone

SYNTHES (USA)

The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Spiral Blade For Humeral Nail (sbhn).

Pre-market Notification Details

Device IDK992348
510k NumberK992348
Device Name:SYNTHES SPIRAL BLADE FOR HUMERAL NAIL (SBHN)
ClassificationNail, Fixation, Bone
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 CodeJDS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-07-14
Decision Date1999-09-23
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
H6794626600 K992348 000
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H6794626400 K992348 000
H679462638S0 K992348 000
H6794626380 K992348 000
H679462636S0 K992348 000
H6794626360 K992348 000
H679462634S0 K992348 000
H679462646S0 K992348 000
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H679462648S0 K992348 000
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H6794626670 K992348 000
H679462666S0 K992348 000
H6794626660 K992348 000
H6794626650 K992348 000
H679462660S0 K992348 000
H679462654S0 K992348 000
H6794626540 K992348 000
H679462652S0 K992348 000
H6794626520 K992348 000
H679462650S0 K992348 000
H6794626500 K992348 000
H6794626340 K992348 000

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