JACKSON MULTIPURPOSE OPERATING TABLE
FDA 510(k) clearance K910736 · decided 1991-05-21
Clearance details
- K-number
- K910736
- Device name
- JACKSON MULTIPURPOSE OPERATING TABLE
- Applicant
- Orthopedic Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1991-02-21
- Decision date
- 1991-05-21
- Days to decision
- 89 days
- Clearance type
- Traditional
- Product code
- JEA
- Device class
- 1
- Regulation number
- 878.4960
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Hayward, CA, US
- Third-party review
- No
- Expedited review
- No
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| ARTHROTRACT UPPER LIMB TRACTION ACCESSORY (K874762) | Andronic Devices, Ltd. | 1987-12-10 |
| ARTHROBOT 101 UPPER LIMB TRACTION ACCESSORY (K873080) | Andronic Devices, Ltd. | 1987-11-25 |
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Mizuho OSI Modular Table System; Product Usage: For use in orthopaedic surgery to provide recall (Z-0073-2012) | Mizuho Orthopedic Systems Inc | 2011-10-27 |