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510(k) K083469

METASURG CANNULATED TIATANIUM HEMI IMPLANT, MODEL HM-1000 by Metasurg — Product Code KWD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 13, 2009
Date Received
November 24, 2008
Clearance Type
Traditional
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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  • K070441 — METASURG SUBTALAR IMPLANT (May 8, 2007)

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  • K203634 — BioPoly Great Toe Hemiarthroplasty Implant (February 2, 2021)
  • K200951 — Accu-Joint Hemi Implant (December 8, 2020)
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  • K161279 — Life Spine Metatarsal Hemi Implant (February 1, 2017)
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