Universal Wrist

FDA 510(k) K940297 · Turnkey Intergration USA, Inc.

Substantially Equivalent for Some Indications

510(k) numberK940297

Submission

Device name
Universal Wrist
Applicant
Turnkey Intergration USA, Inc.
Indianapolis, IN, US
Received
January 21, 1994
Decision date
February 6, 1995
Decision
Substantially Equivalent for Some Indications (SN)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
JWI – Prosthesis, Wrist, 2 Part Metal-Plastic Articulation, Semi-Constrained
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3800
Specialty
Orthopedic
Implant
Yes

Other 510(k)s with product code JWI

510(k)DeviceApplicantDecision
K931265Fixano Total Trapezio Metacarpal Prosthesis, 2NDJWI · Traditional Ferguson Medical05/22/1995SN
K792687Aspergillus Sp., AntigenJWI · Traditional Meridian Diagnostics, Inc.01/17/1980SE

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K953653Lubinus SP II Hip SystemJDG · Traditional 11/06/1995SE
K943986Link Endo Model Revision CupHRS · Traditional 07/05/1995SE
K951355Link Saddle ProthesisKWL · Traditional 05/25/1995SE
K950397System 22 ValveBYE · Traditional 04/14/1995SE

Questions and answers

When was Universal Wrist cleared by the FDA?

Universal Wrist (K940297) received a 510(k) decision of Substantially Equivalent for Some Indications on February 6, 1995, 381 days after the submission was received.

What is the product code of K940297?

The FDA product code is JWI – Prosthesis, Wrist, 2 Part Metal-Plastic Articulation, Semi-Constrained, a Class II (moderate risk) device regulated under 21 CFR 888.3800.