ARTHROBOT 101 UPPER LIMB TRACTION ACCESSORY
FDA 510(k) clearance K873080 · decided 1987-11-25
Clearance details
- K-number
- K873080
- Device name
- ARTHROBOT 101 UPPER LIMB TRACTION ACCESSORY
- Applicant
- Andronic Devices, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1987-08-05
- Decision date
- 1987-11-25
- Days to decision
- 112 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
- Richmond,B.C. V6v-2j2, CA
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| STRYKER COMMAND2 OFFICE CONSOLE (K953071) | Stryker Instruments | 1995-08-08 |
| MEND APC (K924094) | Mend Technologies, Inc. | 1993-03-30 |
| JACKSON MULTIPURPOSE OPERATING TABLE (K910736) | Orthopedic Systems, Inc. | 1991-05-21 |
| ARTHROBOT(TM) WRIST HOLDER ACCESSORY (K911522) | Andronic Devices, Ltd. | 1991-04-29 |
| SKYTRON MODEL 1100 AND MODEL 142 (K900290) | Skytron, Div. the Kmw Group, Inc. | 1990-02-20 |
| DMI 250 SERIES POWER SURGERY TABLE (K894789) | M.D. Intl., Inc. | 1989-08-29 |
| OSI RIZZOLI TRAUMA TABLE (ELECTRIC VERSION) (K881060) | Orthopedic Systems, Inc. | 1988-03-25 |
| ARTHROTRACT UPPER LIMB TRACTION ACCESSORY (K874762) | Andronic Devices, Ltd. | 1987-12-10 |
| ARTHROBOT 100 UPPER LIMB POSITIONER (K873079) | Andronic Devices, Ltd. | 1987-11-25 |
Recalls involving this device
No recalls on record reference this clearance.