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Panels › Orthopedic › Product code KXE · Class 2

Prosthesis, Wrist, Hemi-, Ulnar

Regulation 888.3810

0510(k)s in 12 months (16 all time)

0recalls in 12 months (3 all time)

2recalls that name a 510(k)

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Top companies in KXE

Company	510(k)s	Recalls
Aptis Medical, LLC	5	0
Ascension Orthopedics, Inc.	1	1
Avanta Orthopaedics, Inc.	2	0
Stryker Howmedica Osteonics Corp.	0	2
Ascension Orthopedic	1	0
Cutter Laboratories, Inc.	1	0
Dow Corning Corp. Healthcare Industries Materials	1	0
Kapp Surgical Instrument, Inc.	1	0
Remi Sciences, Inc.	1	0
Small Bone Innovations, Inc.	1	0

Date	Firm and product	Code	Linked 510(k)
Aug 20, 2015	Stryker Howmedica Osteonics Corp. Sigmoid Notch, Radial Plate, Small, Sterile, Do Not Reuse, Rx Only. Intended for replacement of the distal radio-ulnar joint following ulnar head resection arthroplasty. Terminated	KXE	K061146
Aug 20, 2015	Stryker Howmedica Osteonics Corp. uHead, Ulnar Implant, Standard Stem, Size 1, Sterile, Rx Only. Intended for replacement of the distal radioulnar joint following ulnar head resection arthroplasty. Terminated	KXE	K061146
Feb 17, 2012	Ascension Orthopedics, Inc Ascension Orthopedics First Choice Partial Ulnar Head System ("DRUJ System"). Head sizes 14.5 mm, 16.0 mm, 17.5 mm, and 19.0 mm each with stem sizes 4.5 mm, 5.5 mm, or 6.5 mm. The First Choice DRUJ Terminated	KXE	None listed

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