ACUFEX DIRECTOR APPLICATION ANATOMIC GUIDE SYSTEM

Orthopedic Stereotaxic Instrument

SMITH & NEPHEW INC., ENDOSCOPY DIV.

The following data is part of a premarket notification filed by Smith & Nephew Inc., Endoscopy Div. with the FDA for Acufex Director Application Anatomic Guide System.

Pre-market Notification Details

Device IDK111843
510k NumberK111843
Device Name:ACUFEX DIRECTOR APPLICATION ANATOMIC GUIDE SYSTEM
ClassificationOrthopedic Stereotaxic Instrument
Applicant SMITH & NEPHEW INC., ENDOSCOPY DIV. 150 MINUTEMAN RD. Andover,  MA  01810
ContactJanice Haselton
CorrespondentJanice Haselton
SMITH & NEPHEW INC., ENDOSCOPY DIV. 150 MINUTEMAN RD. Andover,  MA  01810
Product CodeOLO  
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-06-29
Decision Date2011-11-14
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00885554024135 K111843 000

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