ASCENSION PYROCARBON LUNATE

Prosthesis, Wrist, Carpal Lunate

ASCENSION ORTHOPEDICS, INC.

The following data is part of a premarket notification filed by Ascension Orthopedics, Inc. with the FDA for Ascension Pyrocarbon Lunate.

Pre-market Notification Details

Device IDK080997
510k NumberK080997
Device Name:ASCENSION PYROCARBON LUNATE
ClassificationProsthesis, Wrist, Carpal Lunate
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 CodeKWN  
CFR Regulation Number888.3750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-04-08
Decision Date2008-06-17
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00885556858769 K080997 000
M269TRL71501T1 K080997 000
M269TRL71502T1 K080997 000
M269TRL71503T1 K080997 000
M269TRL71504T1 K080997 000
M269TRL71505T1 K080997 000
10381780116240 K080997 000
10381780116257 K080997 000
10381780116264 K080997 000
10381780116271 K080997 000
10381780116288 K080997 000
00885556858721 K080997 000
00885556858738 K080997 000
00885556858745 K080997 000
00885556858752 K080997 000
M268PYROLUNINSTP1 K080997 000

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