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510(k) K781380

MARNE M.T.P.J. ORTHOPEDIC IMPLANT by Farah , Ltd. — Product Code KYJ

K781380 is an FDA 510(k) premarket notification submitted by Farah , Ltd. for the device "MARNE M.T.P.J. ORTHOPEDIC IMPLANT". The FDA issued a decision of Substantially Equivalent on February 21, 1979. The device falls under product code KYJ (Prosthesis, Finger, Constrained, Polymer), a Class II device regulated under 21 CFR 888.3230.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 21, 1979
Date Received
August 11, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Finger, Constrained, Polymer
Device Class
Class II
Regulation Number
888.3230
Review Panel
OR
Submission Type

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  • K211385 — KeriFlex® MCP and PIP Finger Joint Prostheses (July 27, 2022)
  • K140453 — OSTEOTEC SILICONE FINGER IMPLANT (April 17, 2015)
  • K083107 — MODIFICATION TO DEPUY NEUFLEX PIP FINGER (February 9, 2009)
  • K082231 — ASCENSION SILICONE PIP (January 12, 2009)
  • K022892 — ASCENSION SILLICONE MCP (November 25, 2002)
  • K013629 — FINGER JOINT PROSTHESIS (January 25, 2002)
  • K001922 — DEPUY NEUFLEX PIP FINGER (August 29, 2000)
  • K970544 — DEPUY DUPONT ORTHOPAEDICS FINGER JOINT PROSTHESIS (September 12, 1997)

FDA data resources