EDWARDS ADJUSTABLE CONNECTORS

Appliance, Fixation, Spinal Interlaminal

SCIENTIFIC SPINAL LTD.

The following data is part of a premarket notification filed by Scientific Spinal Ltd. with the FDA for Edwards Adjustable Connectors.

Pre-market Notification Details

Device IDK915672
510k NumberK915672
Device Name:EDWARDS ADJUSTABLE CONNECTORS
ClassificationAppliance, Fixation, Spinal Interlaminal
Applicant SCIENTIFIC SPINAL LTD. SCHOOL OF MEDICINE DEPTMENT OF SURGERY Baltimore,  MD  21201
ContactCharles C Edwards
CorrespondentCharles C Edwards
SCIENTIFIC SPINAL LTD. SCHOOL OF MEDICINE DEPTMENT OF SURGERY Baltimore,  MD  21201
Product CodeKWP  
CFR Regulation Number888.3050 [🔎]
DecisionSubstantially Equivalent For Some Indications (SN)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-12-17
Decision Date1993-05-26

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