MEND APC
FDA 510(k) clearance K924094 · decided 1993-03-30
Clearance details
- K-number
- K924094
- Device name
- MEND APC
- Applicant
- Mend Technologies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-08-13
- Decision date
- 1993-03-30
- Days to decision
- 229 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
- Dallas, TX, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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| Record | Firm | Date |
|---|---|---|
| STRYKER COMMAND2 OFFICE CONSOLE (K953071) | Stryker Instruments | 1995-08-08 |
| 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 101 UPPER LIMB TRACTION ACCESSORY (K873080) | Andronic Devices, Ltd. | 1987-11-25 |
| ARTHROBOT 100 UPPER LIMB POSITIONER (K873079) | Andronic Devices, Ltd. | 1987-11-25 |
Recalls involving this device
No recalls on record reference this clearance.