INTERMEDICS HIGH TIBIAL OSTEOTOMY SYSTEM

Plate, Fixation, Bone

INTERMEDICS ORTHOPEDICS

The following data is part of a premarket notification filed by Intermedics Orthopedics with the FDA for Intermedics High Tibial Osteotomy System.

Pre-market Notification Details

Device IDK892228
510k NumberK892228
Device Name:INTERMEDICS HIGH TIBIAL OSTEOTOMY SYSTEM
ClassificationPlate, Fixation, Bone
Applicant INTERMEDICS ORTHOPEDICS 1300 EAST ANDERSON LN. BUILDING C Austin,  TX  78752
ContactThomas L Craig
CorrespondentThomas L Craig
INTERMEDICS ORTHOPEDICS 1300 EAST ANDERSON LN. BUILDING C Austin,  TX  78752
Product CodeHRS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-04-05
Decision Date1989-10-06

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00889024172210 K892228 000
00889024172067 K892228 000
00889024172081 K892228 000
00889024172098 K892228 000
00889024172104 K892228 000
00889024172111 K892228 000
00889024172128 K892228 000
00889024172135 K892228 000
00889024172142 K892228 000
00889024172159 K892228 000
00889024172166 K892228 000
00889024172173 K892228 000
00889024172180 K892228 000
00889024172197 K892228 000
00889024172203 K892228 000
00889024259508 K892228 000

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