SUTTER PROXIMAL INTERPHALANGEAL JOINT— 510(k) K931588

Name: FDA 510(k) clearance K931588
Creator: U.S. Food and Drug Administration
Published: 1994-03-10

Substantially Equivalent

Sutter Corp.

FDA 510(k) clearance K931588 for SUTTER PROXIMAL INTERPHALANGEAL JOINT, Substantially Equivalent on 1994-03-10. Applicant: Sutter Corp.. Device class: 2.

Clearance details

Applicant: Sutter Corp.
Product code: Code KYJ
Device class: Class 2
Regulation: 21 CFR 888.3230
Advisory panel: Orthopedic
Date received: 1993-03-31
Decision date: 1994-03-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KYJ

view all

K233670 — Ascension Silicone MCP; Ascension Silicone PIP2023-12-14
K220142 — BRM Digitalis Spacer2023-04-04
K211385 — KeriFlex® MCP and PIP Finger Joint Prostheses2022-07-27
K140453 — OSTEOTEC SILICONE FINGER IMPLANT2015-04-17
K083107 — MODIFICATION TO DEPUY NEUFLEX PIP FINGER2009-02-09

More clearances from Sutter Corp.

view all

K943354 — SUTTER HAMMERTOE JOINT PROSTHESIS1995-06-12
K945221 — SUTTER MODEL 6000 HAND CPM DEVICE1995-02-27
K924654 — FIRST METATARSOPHALANGEAL JOINT MOTION SPLINT1993-02-22
K914860 — SUTTER MODEL 10000 LEG CPM DEVICE1992-01-08
K902707 — MODEL 9000 AT ANKLE CPM DEVICE1990-07-25

Adverse events under product code KYJ

product code KYJ

Injury: 210
Total: 210

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.