Home / 510(k) Clearances / K140453

510(k) K140453

OSTEOTEC SILICONE FINGER IMPLANT by Osteotec, Ltd. — Product Code KYJ

K140453 is an FDA 510(k) premarket notification submitted by Osteotec, Ltd. for the device "OSTEOTEC SILICONE FINGER IMPLANT". The FDA issued a decision of Substantially Equivalent on April 17, 2015. 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
April 17, 2015
Date Received
February 24, 2014
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

Other clearances for product code KYJ

  • K233670 — Ascension Silicone MCP; Ascension Silicone PIP (December 14, 2023)
  • K220142 — BRM Digitalis Spacer (April 4, 2023)
  • K211385 — KeriFlex® MCP and PIP Finger Joint Prostheses (July 27, 2022)
  • 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)
  • K931588 — SUTTER PROXIMAL INTERPHALANGEAL JOINT (March 10, 1994)

FDA data resources