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510(k) K870200

SUTTER FINGER JOINT PROSTHESIS by Sutter Biomedical, Inc. — Product Code KYJ

K870200 is an FDA 510(k) premarket notification submitted by Sutter Biomedical, Inc. for the device "SUTTER FINGER JOINT PROSTHESIS". The FDA issued a decision of Substantially Equivalent on October 9, 1987. The device falls under product code KYJ (Prosthesis, Finger, Constrained, Polymer), a Class II device regulated under 21 CFR 888.3230. Sutter Biomedical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 9, 1987
Date Received
January 20, 1987
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 by Sutter Biomedical, Inc.

  • K875249 — SUTTER PHALANGEAL CAP (February 3, 1988)
  • K861983 — SUTTER LESSER METATARSAL CAP (September 8, 1986)
  • K850274 — SUTTER CPM 9000 -NONMEASURING EXERCISE EQUIPMENT (April 25, 1985)
  • K830974 — SUTTER CPM 5000 (April 12, 1983)
  • K830649 — SUTTER CPM 2000 (March 17, 1983)
  • K823539 — SUTTER CPM (January 14, 1983)
  • K820813 — LESSER METATARSAL PHALANG. JOINT PROSTH (May 21, 1982)
  • K820083 — SUTTER CPM (January 28, 1982)
  • K812691 — SILICONE IMPLANTS (November 16, 1981)
  • K802342 — PROXIMAL INTERPHALANGEAL JOINT IMPLANT (October 14, 1981)

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)
  • 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