ASCENSION ANKLE FUSION PLATE SYSTEM

Plate, Fixation, Bone

ASCENSION ORTHOPEDICS, INC.

The following data is part of a premarket notification filed by Ascension Orthopedics, Inc. with the FDA for Ascension Ankle Fusion Plate System.

Pre-market Notification Details

Device IDK100176
510k NumberK100176
Device Name:ASCENSION ANKLE FUSION PLATE SYSTEM
ClassificationPlate, Fixation, Bone
Applicant ASCENSION ORTHOPEDICS, INC. 8700 CAMERON RD., STE. 100 Austin,  TX  78754 -3832
ContactDebbie Stearns
CorrespondentDebbie Stearns
ASCENSION ORTHOPEDICS, INC. 8700 CAMERON RD., STE. 100 Austin,  TX  78754 -3832
Product CodeHRS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-01-21
Decision Date2010-06-16
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
M269PSS4555LT1 K100176 000
M269PSS4534LT1 K100176 000
M269PSS4534CT1 K100176 000
M269PSS4532LT1 K100176 000
M269PSS4532CT1 K100176 000
M269PSS4530LT1 K100176 000
M269PSS4530CT1 K100176 000
M269PSS4528LT1 K100176 000
M269PSS4528CT1 K100176 000
M269PSS4536CT1 K100176 000
M269PSS4536LT1 K100176 000
M269PSS4538CT1 K100176 000
M269PSS4555CT1 K100176 000
M269PSS4550LT1 K100176 000
M269PSS4550CT1 K100176 000
M269PSS4545LT1 K100176 000
M269PSS4545CT1 K100176 000
M269PSS4540LT1 K100176 000
M269PSS4540CT1 K100176 000
M269PSS4538LT1 K100176 000
M269PSS4526LT1 K100176 000
M269PSS4526CT1 K100176 000
M269PSS4524LT1 K100176 000
M269AFPA09RT1 K100176 000
M269AFPA09LT1 K100176 000
M269AFPA07RT1 K100176 000
M269AFPA07LT1 K100176 000
M269PSS6575CT1 K100176 000
M269PSS6555LT1 K100176 000
M269PSS6532CT1 K100176 000
M269PSS4514LT1 K100176 000
M269AFPL09LT1 K100176 000
M269PSS4514CT1 K100176 000
M269PSS4516CT1 K100176 000
M269PSS4524CT1 K100176 000
M269PSS4522LT1 K100176 000
M269PSS4522CT1 K100176 000
M269PSS4520LT1 K100176 000
M269PSS4520CT1 K100176 000
M269PSS4518LT1 K100176 000
M269PSS4518CT1 K100176 000
M269PSS4516LT1 K100176 000
M269AFPL09RT1 K100176 000
10381780064619 K100176 000
M269PSS6555CT1 K100176 000
M269PSS6550LT1 K100176 000
M269PSS6550CT1 K100176 000
M269PSS6545LT1 K100176 000
M269PSS6545CT1 K100176 000
M269PSS6540LT1 K100176 000
M269PSS6540CT1 K100176 000
M269PSS6538LT1 K100176 000
M269PSS6560CT1 K100176 000
M269PSS6560LT1 K100176 000
M269PSS6565CT1 K100176 000
10381780064602 K100176 000
M268AFPIMP1 K100176 000
M269PSS6580LT1 K100176 000
M269PSS6580CT1 K100176 000
M269PSS6575LT1 K100176 000
M269PSS6570LT1 K100176 000
M269PSS6570CT1 K100176 000
M269PSS6565LT1 K100176 000
M269PSS6538CT1 K100176 000
M269PSS6536LT1 K100176 000
M269PSS6536CT1 K100176 000
M269PSS4580CT1 K100176 000
M269PSS4575LT1 K100176 000
M269PSS4575CT1 K100176 000
M269PSS4570LT1 K100176 000
M269PSS4570CT1 K100176 000
M269PSS4565LT1 K100176 000
M269PSS4565CT1 K100176 000
M269PSS4560LT1 K100176 000
M269PSS4580LT1 K100176 000
M269PSS6520LT1 K100176 000
M269PSS6522LT1 K100176 000
M269PSS6534LT1 K100176 000
M269PSS6534CT1 K100176 000
M269PSS6532LT1 K100176 000
M269PSS6530LT1 K100176 000
M269PSS6530CT1 K100176 000
M269PSS6528LT1 K100176 000
M269PSS6526LT1 K100176 000
M269PSS6524LT1 K100176 000
M269PSS4560CT1 K100176 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.