Product code FWW
- Device name
- Table, Operating-Room, Pneumatic
- Medical specialty
- General, Plastic Surgery
- Device class
- 1
- Regulation number
- 878.4960
- Review panel
- SU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K953961 | OSTEONICS INSIGHT KNEE POSITIONING & ALIGNMENT SYSTEM | Osteonics Corp. | 1995-11-29 |
| K935356 | CAPTAIN'S CHAIR ACCESSORY TO AMSCO SURGICAL TABLES | Amsco American Sterilizer Co. | 1994-03-23 |
| K931876 | FISK ARM SUPPORT | Vvortex International Corp. | 1993-09-09 |
| K924713 | UNIVERSAL SURGICAL INSTRUMENT HOLDER | T. Korossurgical Instruments Corp. | 1993-05-17 |
| K863161 | TABLE, OPERATING ROOM, HYDRAULIC | Kamiya Tsusan Kaisha, Ltd. | 1986-09-05 |
| K853479 | SKYTRON ELITE 300 SURGERY TABLE | Skytron, Div. the Kmw Group, Inc. | 1985-09-05 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00190376678801 | ATEC A.R.M. | ALPHATEC SPINE, INC. | 2025-12-23 |
| 00190376678887 | ATEC A.R.M. | ALPHATEC SPINE, INC. | 2025-12-23 |
| 00190376678788 | ATEC A.R.M. | ALPHATEC SPINE, INC. | 2025-12-23 |
| 00190376678757 | ATEC A.R.M. | ALPHATEC SPINE, INC. | 2025-12-23 |
| 00190376678740 | ATEC A.R.M. | ALPHATEC SPINE, INC. | 2025-12-23 |
| 00190376678672 | ATEC A.R.M. | ALPHATEC SPINE, INC. | 2025-12-23 |
| 00190376678832 | ATEC A.R.M. | ALPHATEC SPINE, INC. | 2025-12-23 |
| 00190376678825 | ATEC A.R.M. | ALPHATEC SPINE, INC. | 2025-12-23 |
| 00190376678818 | ATEC A.R.M. | ALPHATEC SPINE, INC. | 2025-12-23 |
| 00190376678795 | ATEC A.R.M. | ALPHATEC SPINE, INC. | 2025-12-23 |
| 00190376678771 | ATEC A.R.M. | ALPHATEC SPINE, INC. | 2025-12-23 |
| 00190376678764 | ATEC A.R.M. | ALPHATEC SPINE, INC. | 2025-12-23 |
| 00190376678689 | ATEC A.R.M. | ALPHATEC SPINE, INC. | 2025-12-23 |
| 00190376678665 | ATEC A.R.M. | ALPHATEC SPINE, INC. | 2025-12-23 |
| 00190376729473 | ATEC A.R.M. | ALPHATEC SPINE, INC. | 2025-12-23 |
| 00190376532417 | ATEC A.R.M. | ALPHATEC SPINE, INC. | 2025-03-14 |
| 00190376532394 | ATEC A.R.M. | ALPHATEC SPINE, INC. | 2025-03-14 |
| 00190376532424 | ATEC A.R.M. | ALPHATEC SPINE, INC. | 2025-03-14 |
| 00190376537092 | ATEC A.R.M. | ALPHATEC SPINE, INC. | 2025-03-14 |
| 00190376532448 | ATEC A.R.M. | ALPHATEC SPINE, INC. | 2025-03-14 |
| 00190376532400 | ATEC A.R.M. | ALPHATEC SPINE, INC. | 2025-03-14 |
| 00724995155018 | Amsco | STERIS CORPORATION | 2021-08-05 |