Product code DWH
- Device name
- Blade, Saw, Surgical, Cardiovascular
- Medical specialty
- General, Plastic Surgery
- Device class
- 1
- Regulation number
- 878.4820
- 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 |
|---|---|---|---|
| K904352 | CODMAN COLLINS RADIOPARENT STERNAL BLADES | Codman & Shurtleff, Inc. | 1990-11-21 |
| K862474 | HALL STERNUM SAW | Hall Surgical, Division of Zimmer, Inc. | 1986-07-17 |
| K850483 | MICRO-AIRE STERNUM SAW REPLACEMENT BLADES | Micro-Aire Surgical Instruments, Inc. | 1985-03-01 |
| K830189 | CARDIOVASCULAR SAW BLADES | Temp Medical Products, Inc. | 1983-03-24 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08809260475564 | TRAUS | Saeshin Precision Co., Ltd. | 2026-04-09 |
| 08809260475571 | TRAUS | Saeshin Precision Co., Ltd. | 2026-04-09 |
| 08809260475588 | TRAUS | Saeshin Precision Co., Ltd. | 2026-04-09 |
| 08809260475595 | TRAUS | Saeshin Precision Co., Ltd. | 2026-04-09 |
| 08809260475601 | TRAUS | Saeshin Precision Co., Ltd. | 2026-04-09 |
| 00887482085493 | Symmetry Jacobson | ASPEN SURGICAL PRODUCTS, INC. | 2022-09-22 |
| 00887482073049 | Symmetry Wolff-Boehler | ASPEN SURGICAL PRODUCTS, INC. | 2022-09-16 |
| 00190776162993 | Millennium | Avalign Technologies, Inc. | 2021-11-01 |
| 00190776163006 | Millennium | Avalign Technologies, Inc. | 2021-11-01 |
| 00190776163013 | Millennium | Avalign Technologies, Inc. | 2021-11-01 |
| 00190776163020 | Millennium | Avalign Technologies, Inc. | 2021-11-01 |
| 17630055509618 | Short Microsaw Blade 27x0.6mm | Bien-Air Surgery SA | 2021-02-22 |
| 17630055509670 | Long Microsaw Blade 27x0.6mm | Bien-Air Surgery SA | 2021-02-22 |
| 17630055509625 | Short Microsaw Blade 32x0.6mm | Bien-Air Surgery SA | 2021-02-22 |
| 17630055509632 | Long Microsaw Blade 22x0.4mm | Bien-Air Surgery SA | 2021-02-22 |
| 17630055509649 | Long Microsaw Blade 27x0.4mm | Bien-Air Surgery SA | 2021-02-22 |
| 17630055509656 | Long Microsaw Blade 32x0.4mm | Bien-Air Surgery SA | 2021-02-22 |
| 17630055509663 | Long Microsaw Blade 22x0.6mm | Bien-Air Surgery SA | 2021-02-22 |
| 17630055509601 | Short Microsaw Blade 22x0.6mm | Bien-Air Surgery SA | 2021-02-22 |
| 17630055509595 | Short Microsaw Blade 32x0.4mm | Bien-Air Surgery SA | 2021-02-22 |
| 17630055509588 | Short Microsaw Blade 27x0.4mm | Bien-Air Surgery SA | 2021-02-22 |
| 17630055509472 | Short Microsaw Blade 22x0.4mm | Bien-Air Surgery SA | 2021-02-22 |
| 17630055509687 | Long Microsaw Blade 32x0.6mm | Bien-Air Surgery SA | 2021-02-22 |
| 04046963091521 | AESCULAP | Aesculap AG | 2020-05-08 |
| 04046963413675 | AESCULAP | Aesculap AG | 2020-05-08 |
| 04046963839345 | AESCULAP | Aesculap AG | 2020-05-08 |
| 07613153097709 | NA | STRYKER CORPORATION | 2018-09-23 |
| 04546540042101 | NA | STRYKER CORPORATION | 2018-09-23 |
| 04546540897923 | NA | STRYKER CORPORATION | 2018-09-23 |
| 07613154501144 | Stryker Performance Series | STRYKER CORPORATION | 2018-09-23 |