ASCENSION MODULAR RADIAL HEAD

Prosthesis, Elbow, Hemi-, Radial, Polymer

ASCENSION ORTHOPEDICS, INC.

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

Pre-market Notification Details

• Device ID: K032686
• 510k Number: K032686
• Device Name: ASCENSION MODULAR RADIAL HEAD
• Classification: Prosthesis, Elbow, Hemi-, Radial, Polymer
• Applicant: ASCENSION ORTHOPEDICS, INC. 8200 CAMERON RD., SUITE C-140 Austin, TX 78754 -3832
• Contact: Peter Strzepa
• Correspondent: Peter Strzepa; ASCENSION ORTHOPEDICS, INC. 8200 CAMERON RD., SUITE C-140 Austin, TX 78754 -3832
• Product Code: KWI
• CFR Regulation Number: 888.3170 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2003-08-29
• Decision Date: 2003-10-22
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00885556857496	K032686	000
00885556857380	K032686	000
00885556857397	K032686	000
00885556857403	K032686	000
00885556857410	K032686	000
00885556857427	K032686	000
00885556857434	K032686	000
00885556857441	K032686	000
M268MRADHDINSTP1	K032686	000
M269TRL310011	K032686	000
M269TRL310021	K032686	000
M269TRL310031	K032686	000
00885556857373	K032686	000
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00885556857502	K032686	000
00885556857519	K032686	000
00885556857526	K032686	000
00885556857533	K032686	000
00885556857540	K032686	000
00885556857557	K032686	000
00885556857564	K032686	000
00885556857571	K032686	000
00885556857588	K032686	000
00885556857595	K032686	000
00885556857601	K032686	000
M269TRL310041	K032686	000
M269TRL31020L1	K032686	000
M269TRL31020S1	K032686	000
10381780114512	K032686	000
10381780114529	K032686	000
M269TRL35120L1	K032686	000
M269TRL35120S1	K032686	000
M269TRL35122L1	K032686	000
M269TRL35122S1	K032686	000
M269TRL35124L1	K032686	000
M269TRL35124S1	K032686	000
M269TRL35222L1	K032686	000
M269TRL35222S1	K032686	000
M269TRL35224L1	K032686	000
10381780114505	K032686	000
10381780114499	K032686	000
10381780114482	K032686	000
M269TRL31022L1	K032686	000
M269TRL31022S1	K032686	000
M269TRL31024L1	K032686	000
M269TRL31024S1	K032686	000
M269TRL35220L1	K032686	000
M269TRL35220S1	K032686	000
10381780114437	K032686	000
10381780114444	K032686	000
10381780114451	K032686	000
10381780114468	K032686	000
10381780114475	K032686	000
M269TRL35224S1	K032686	000