SUTTER HAMMERTOE JOINT PROSTHESIS— 510(k) K943354

Substantially Equivalent

Sutter Corp.

FDA 510(k) clearance K943354 for SUTTER HAMMERTOE JOINT PROSTHESIS, Substantially Equivalent on 1995-06-12. Applicant: Sutter Corp.. Device class: 2.

Clearance details

Applicant: Sutter Corp.
Product code: Code KWH
Device class: Class 2
Regulation: 21 CFR 888.3720
Advisory panel: Orthopedic
Date received: 1994-07-12
Decision date: 1995-06-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Sutter Corp.

K945221 — SUTTER MODEL 6000 HAND CPM DEVICE1995-02-27
K931588 — SUTTER PROXIMAL INTERPHALANGEAL JOINT1994-03-10
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

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