510(k) K881060
- Device
- OSI RIZZOLI TRAUMA TABLE (ELECTRIC VERSION)
- Applicant
- ORTHOPEDIC SYSTEMS, INC.
- 510(k) number
- K881060
- Product code
- JEA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1988-03-25
- Date received
- 1988-03-04
- Regulation
- 878.4960
- Classification name
- Table, Surgical With Orthopedic Accessories, Ac-powered
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- ROBERT R MOORE
- Address
- 1897 National Ave. Hayward CA US 94545 94545
FDA Registration Numbers#
- 2916273
- 3010890274
- 8043933
- 3015223105
- 9681642
- 3012329926
- 3007031002
- 1000351276
- 3027847726
- 1043572
- 3043007473
- 3003923584
- 9680168
- 3013522950
- 2221819
- 1066635
- 3031563141
- 3009760038
- 3013836619
- 3012995405
- 3011111237
- 8010652
- 2921578
- 3007143268
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JEA #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K953071 | STRYKER COMMAND2 OFFICE CONSOLE | Stryker Instruments | 1995-08-08 |
| K924094 | MEND APC | Mend Technologies, Inc. | 1993-03-30 |
| K910736 | JACKSON MULTIPURPOSE OPERATING TABLE | Orthopedic Systems, Inc. | 1991-05-21 |
| K911522 | ARTHROBOT(TM) WRIST HOLDER ACCESSORY | Andronic Devices, Ltd. | 1991-04-29 |
| K900290 | SKYTRON MODEL 1100 AND MODEL 142 | Skytron, Div. the Kmw Group, Inc. | 1990-02-20 |
| K894789 | DMI 250 SERIES POWER SURGERY TABLE | M.D. Intl., Inc. | 1989-08-29 |
| K874762 | ARTHROTRACT UPPER LIMB TRACTION ACCESSORY | Andronic Devices, Ltd. | 1987-12-10 |
| K873079 | ARTHROBOT 100 UPPER LIMB POSITIONER | Andronic Devices, Ltd. | 1987-11-25 |
| K873080 | ARTHROBOT 101 UPPER LIMB TRACTION ACCESSORY | Andronic Devices, Ltd. | 1987-11-25 |
Legacy Summary#
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FDA Review#
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