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510(k) K081876

OSTEOMED RESURFACING METATARSAL IMPLANT WITH HYDROXYLAPATITE COATING by Osteomed LP — Product Code KWD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 1, 2008
Date Received
July 2, 2008
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Toe, Hemi-, Phalangeal
Device Class
Class II
Regulation Number
888.3730
Review Panel
OR
Submission Type

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  • K161279 — Life Spine Metatarsal Hemi Implant (February 1, 2017)
  • K152454 — HemiCAP MTP Resurfacing Hemi-Arthroplasty System (April 11, 2016)