UNIVERSAL WRIST— 510(k) K940297
Substantially Equivalent for Some IndicationsTurnkey Intergration USA, Inc.
FDA 510(k) clearance K940297 for UNIVERSAL WRIST, Substantially Equivalent for Some Indications on 1995-02-06. Applicant: Turnkey Intergration USA, Inc.. Device class: 2.
Clearance details
- Applicant
- Turnkey Intergration USA, Inc.
- Product code
- Code JWI
- Device class
- Class 2
- Regulation
- 21 CFR 888.3800
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent for Some Indications
- Clearance type
- Traditional
- Location
- Indianapolis, IN, US
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