STABILIZER SOFT TISSUE ANCHOR 5MM MODEL TA1005, ANCHOR INSERTER/SUTURE ORGANIZER 5MM AI1005, STABILIZER DRILL 5MM NONSTE

K Number: K973031 · Decision Nov 3, 1997

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FEI Numbers

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159

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Device Name: STABILIZER SOFT TISSUE ANCHOR 5MM MODEL TA1005, ANCHOR INSERTER/SUTURE ORGANIZER 5MM AI1005, STABILIZER DRILL 5MM NONSTE
K Number: K973031
Device Class: FDA class 1
Clearance Type: Traditional
Regulation Number: 890.3490
Medical Specialty: Physical Medicine
Decision: Substantially Equivalent
Statement or Summary: Summary
Applicant: R. Thomas Grotz, M.D., Inc.
Date Received: August 14, 1997
Decision Date: November 3, 1997
Product Code: MRI
Advisory Committee: Physical Medicine
Review Advisory Committee: PM
Third Party: N

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code	Device Name	Device Class	Medical Specialty
MRI	Orthosis, Truncal/Orthosis, Limb	FDA class 1	Physical Medicine

Other 510(k) clearances with the same product code (MRI), ordered by most recent decision date.

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K Number	Device Name	Decision Date	Decision
K984200	STABILIZER SOFT TISSUE ANCHOR, 5 AND 8MM; ANCHOR INSERTER, 5 AND 8MM; STABILIZER DRILL, 5 AND 8MM, NONSTERILE; STABILIZE	Jan 21, 1999	Substantially Equivalent
K965111	STABILIZER SOFT TISSUE ANCHOR MODEL NUMBER TA1005, TA1008, ANCHOR INSERTER/SUTURE ORGANIZER MODEL NUMBERS AI1005, AI1008	Feb 18, 1997	Substantially Equivalent
K964927	STABILIZER SOFT TISSUE ANCHOR, 8MM MODEL TA1008, ANCHOR INSERTER/SUTURE ORGANIZER, 8MM MODEL AI1008, STABILIZER DRILL, 8	Feb 7, 1997	Substantially Equivalent