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510(k) K931588

SUTTER PROXIMAL INTERPHALANGEAL JOINT by Sutter Corp. — Product Code KYJ

K931588 is an FDA 510(k) premarket notification submitted by Sutter Corp. for the device "SUTTER PROXIMAL INTERPHALANGEAL JOINT". The FDA issued a decision of Substantially Equivalent on March 10, 1994. The device falls under product code KYJ (Prosthesis, Finger, Constrained, Polymer), a Class II device regulated under 21 CFR 888.3230. Sutter Corp. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 10, 1994
Date Received
March 31, 1993
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 Corp.

  • K943354 — SUTTER HAMMERTOE JOINT PROSTHESIS (June 12, 1995)
  • K945221 — SUTTER MODEL 6000 HAND CPM DEVICE (February 27, 1995)
  • K924654 — FIRST METATARSOPHALANGEAL JOINT MOTION SPLINT (February 22, 1993)
  • K914860 — SUTTER MODEL 10000 LEG CPM DEVICE (January 8, 1992)
  • K902707 — MODEL 9000 AT ANKLE CPM DEVICE (July 25, 1990)
  • K890607 — SUTTER HOSPITAL CPM (February 27, 1989)

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