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510(k) K111068

STABLYX CMC ARTHROPLASTY IMPLANT MODEL SIZES 1, 2, 3, 4, AND 5 by Skeletal Dynamics, LLC — Product Code KYI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 30, 2011
Date Received
April 18, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Wrist, Carpal Trapezium
Device Class
Class II
Regulation Number
888.3770
Review Panel
OR
Submission Type

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Other clearances for product code KYI

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  • K061451 — ASCENSION, MODELS CMC-400,13,CMC-400-20,CMC-400-30,CMC-400-40 (August 11, 2006)
  • K061089 — MODULAR THUMB IMPLANT, MODELS 17600, 17601, 17602, 17603, 17596, 17597, 17598, 1 (June 20, 2006)
  • K060386 — NEXA CARPO METACARPAL IMPLANT (May 10, 2006)
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