ARTOS, DIPLOS SYSTEM
FDA 510(k) clearance K970284 · decided 1997-04-21
Clearance details
- K-number
- K970284
- Device name
- ARTOS, DIPLOS SYSTEM
- Applicant
- Turnkey Intergration USA, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-01-24
- Decision date
- 1997-04-21
- Days to decision
- 87 days
- Clearance type
- Traditional
- Product code
- KWY
- Device class
- 2
- Regulation number
- 888.3390
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Sarasota, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.