510(k) K880263
- Device
- OSI RIZZOLI ORTHOPEDIC TABLE/MANUAL VERSION
- Applicant
- ORTHOPEDIC SYSTEMS, INC.
- 510(k) number
- K880263
- Product code
- JEB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1988-03-15
- Date received
- 1988-01-22
- Regulation
- 878.4950
- Classification name
- Table, Surgical With Orthopedic Accessories, Manual
- 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#
- 3010160370
- 3004142400
- 3015223105
- 1818910
- 3004215117
- 3009590742
- 3009662890
- 8010370
- 1825034
- 1061124
- 1417592
- 1000351276
- 1043572
- 3004464325
- 1836161
- 9680168
- 1060917
- 3025430561
- 9616944
- 3008114965
- 3009973699
- 3004976965
- 1526439
- 3011566436
- 3004986960
- 1833053
- 3035641086
- 3004111573
- 3022435839
- 3006460162
- 1423537
- 1223662
- 9616088
- 3009715914
- 2936485
- 3006591312
- 8030607
- 2434839
- 1221934
- 9680104
- 3014680784
- 9612277
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JEB #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K905816 | ORTHOVISION TABLE | American Sterilizer Co. | 1991-03-06 |
| K900405 | SCHOLTEN FRAME | Scholten Surgical Instruments, Inc. | 1990-03-01 |
| K891917 | ORTHO-J, INC. BEK-JS-004 | Ortho-J, Inc. | 1989-05-26 |
| K891387 | WILLIAMS BELT & BOOT | Arthro-Medic, Inc. | 1989-05-23 |
| K881101 | K ORTHOPEDIC TABLE | Instrumentation Specialties, Inc. | 1988-04-06 |
| K873273 | ORTHOPAEDIC TABLE 1420 | Stierlen-Maquet AG | 1987-09-17 |
| K873274 | PLASTER TABLE 1418 | Stierlen-Maquet AG | 1987-09-17 |
| K873275 | EXTENSION TABLE 1417 | Stierlen-Maquet AG | 1987-09-17 |
| K873276 | EXTENSION DEVICE 1416 | Stierlen-Maquet AG | 1987-09-17 |
| K781082 | CAST BLOCK | Orthopedic Equipment Co., Inc. | 1978-07-07 |
| K772321 | ARTHROSTRESS | Mtd, Inc. | 1978-01-03 |
| K771020 | SPINAL SURGERY FRAME | Orthopedic Systems, Inc. | 1977-06-17 |
Legacy Summary#
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FDA Review#
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