Mend Apc
FDA 510(k) K924094 · Mend Technologies, Inc.
510(k) numberK924094
Submission
- Device name
- Mend Apc
- Applicant
- Mend Technologies, Inc.
Dallas, TX, US - Received
- August 13, 1992
- Decision date
- March 30, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JEA – Table, Surgical With Orthopedic Accessories, Ac-Powered
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4960
- Specialty
- General, Plastic Surgery
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| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K953071 | Stryker COMMAND2 Office ConsoleJEA · Traditional | Stryker Instruments | 08/08/1995SE |
| K910736 | Jackson Multipurpose Operating TableJEA · Traditional | Orthopedic Systems, Inc. | 05/21/1991SE |
| K911522 | Arthrobot(Tm) Wrist Holder AccessoryJEA · Traditional | Andronic Devices, Ltd. | 04/29/1991SE |
| K900290 | Skytron Model 1100 and Model 142JEA · Traditional | Skytron, Div. the Kmw Group, Inc. | 02/20/1990SE |
| K894789 | Dmi 250 Series Power Surgery TableJEA · Traditional | M.D. Intl., Inc. | 08/29/1989SE |
| K881060 | Osi Rizzoli Trauma Table (Electric Version)JEA · Traditional | Orthopedic Systems, Inc. | 03/25/1988SE |
| K874762 | Arthrotract Upper Limb Traction AccessoryJEA · Traditional | Andronic Devices, Ltd. | 12/10/1987SE |
| K873080 | Arthrobot 101 Upper Limb Traction AccessoryJEA · Traditional | Andronic Devices, Ltd. | 11/25/1987SE |
| K873079 | Arthrobot 100 Upper Limb PositionerJEA · Traditional | Andronic Devices, Ltd. | 11/25/1987SE |
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Questions and answers
When was Mend Apc cleared by the FDA?
Mend Apc (K924094) received a 510(k) decision of Substantially Equivalent on March 30, 1993, 229 days after the submission was received.
What is the product code of K924094?
The FDA product code is JEA – Table, Surgical With Orthopedic Accessories, Ac-Powered, a Class I (low risk) device regulated under 21 CFR 878.4960.