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 ID: K100176
• 510k Number: K100176
• Device Name: ASCENSION ANKLE FUSION PLATE SYSTEM
• Classification: Plate, Fixation, Bone
• Applicant: ASCENSION ORTHOPEDICS, INC. 8700 CAMERON RD., STE. 100 Austin, TX 78754 -3832
• Contact: Debbie Stearns
• Correspondent: Debbie Stearns; ASCENSION ORTHOPEDICS, INC. 8700 CAMERON RD., STE. 100 Austin, TX 78754 -3832
• Product Code: HRS
• CFR Regulation Number: 888.3030 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2010-01-21
• Decision Date: 2010-06-16
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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