510(k) K020274

WMT MODULAR ULNAR HEAD IMPLANT by Wrightmedicaltechnologyinc — Product Code KXE

K020274 is an FDA 510(k) premarket notification submitted by Wrightmedicaltechnologyinc for the device "WMT MODULAR ULNAR HEAD IMPLANT". The FDA issued a decision of Substantially Equivalent on February 22, 2002. The device falls under product code KXE (Prosthesis, Wrist, Hemi-, Ulnar), a Class II device regulated under 21 CFR 888.3810. Wrightmedicaltechnologyinc has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 22, 2002
Date Received
January 28, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Wrist, Hemi-, Ulnar
Device Class
Class II
Regulation Number
888.3810
Review Panel
OR
Submission Type