Product code GFA
- Device name
- Blade, Saw, General & Plastic Surgery, Surgical
- 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 |
|---|---|---|---|
| K971978 | GRAFT HARVESTING SAWBLADES | Wrightmedicaltechnologyinc | 1997-06-18 |
| K954483 | STRYKER SAGITTAL SAW ATTACHMENT | Stryker Instruments | 1996-01-30 |
| K955229 | WRIGHT MEDICAL TECHNOLOGY SAWBLADES | Wrightmedicaltechnologyinc | 1996-01-18 |
| K953012 | DISPOSABLE & REUSABLE SURGICAL CUTTING TOOLS | Boston Surgical Products, Inc. | 1995-07-12 |
| K950403 | SURGICAL SAW BLADES | Transidyne General Corp. | 1995-02-21 |
| K940501 | RE-SHARPENABLE SAW BLADES | Adven Medical | 1994-06-28 |
| K933595 | BUR, SURGICAL, GENERAL & PLASTIC SURGERY | Omega Surgical Instruments, Inc. | 1994-03-16 |
| K935391 | SARNS STERNAL SAW II, STERNAL SAW II BLADE, SARNS SAW BLADES-NON-STERILE BULK PACK | 3M Health Care, Sarns | 1994-02-24 |
| K934603 | SURGICAL SAW BLADES | American Medical Specialties, Inc. | 1994-02-22 |
| K931769 | SNAP OSCILLATING SAW | Surgiquip, Inc. | 1994-01-27 |
| K934390 | OSCILLATING BONE SAW BLADE, 6200 SERIES | Boehringer Laboratories | 1994-01-26 |
| K931210 | INTERMEDICS ORTHOPEDICS SAW BLADE | Intermedics Orthopedics | 1993-11-18 |
| K933298 | SAW BLADE | Omega Surgical Instruments, Inc. | 1993-08-09 |
| K924953 | FLUID COOLED BONE SAW BLADE, 6000 SERIES | Boehringer Laboratories | 1993-01-21 |
| K912761 | SURGICAL SAW BLADES | Blairden Precision Instruments, Inc. | 1991-07-19 |
| K896280 | MICRO-AIRE OSCILLATING SAW BLADE 202C-25, 202C-50 | Micro-Aire Surgical Instruments, Inc. | 1989-11-22 |
| K863788 | SAWBLADE | Tava Surgical Instruments | 1986-10-14 |
| K861876 | CRANIO BLADES AND WIRE PASS DRILL | New England Surgical Instrument Corp. | 1986-05-30 |
| K854192 | ANADIAS NASAL SAW BLADES | Anadias, Inc. | 1985-11-13 |
| K851880 | BRIMFIELD SCIEN. INSTRU. DISPOS. STERILE SURG. BLA | J-Pac, LLC | 1985-05-21 |
| K831714 | MICRO-AIRE REPLACEMENT SURG. SAW BLADE | Micro-Aire Surgical Instruments, Inc. | 1983-07-07 |
| K830434 | DISPOSABLE INTRA-ARTICULAR BLADE | Concept, Inc. | 1983-04-12 |
| K821487 | MICRO-SURGICAL POWER INSTRUMENT SYS. | Spire Medical, Inc. | 1982-07-02 |
| K820601 | REPLACEMENT SAW BLADES FOR STRYKER AIR | Micro-Aire Surgical Instruments, Inc. | 1982-03-23 |
| K811506 | MICRO-AIRE REPLACEMENT SAW BLADES | Micro-Aire Surgical Instruments, Inc. | 1981-08-13 |
| K810045 | I.M. RETROGRADE BLADES | Hogan & Hartson | 1981-02-12 |
| K802838 | STERNUM SAW BLADE | Amsco Co. | 1980-12-11 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07613327054989 | Formula | STRYKER CORPORATION | 2019-07-23 |
| 07613327054972 | ParallelPortal | STRYKER CORPORATION | 2019-07-23 |
| 07613327054965 | Formula | STRYKER CORPORATION | 2019-07-23 |
| 07613327054958 | ParallelPortal | STRYKER CORPORATION | 2019-07-23 |
| 07613327054941 | ParallelPortal | STRYKER CORPORATION | 2019-07-23 |
| 07613327054934 | ParallelPortal | STRYKER CORPORATION | 2019-07-23 |
| 07613327054927 | ParallelPortal | STRYKER CORPORATION | 2019-07-23 |
| 07613327054910 | ParallelPortal | STRYKER CORPORATION | 2019-07-23 |
| 07613327054828 | Formula | STRYKER CORPORATION | 2018-09-12 |
| 07613327054880 | Formula | STRYKER CORPORATION | 2018-09-12 |
| 07613327054873 | Formula | STRYKER CORPORATION | 2018-09-12 |
| 07613327054866 | Formula | STRYKER CORPORATION | 2018-09-12 |
| 07613327054859 | Formula | STRYKER CORPORATION | 2018-09-12 |
| 07613327054842 | Formula | STRYKER CORPORATION | 2018-09-12 |
| 07613327054835 | Formula | STRYKER CORPORATION | 2018-09-12 |
| 07613327054811 | Formula | STRYKER CORPORATION | 2018-09-12 |
| 07613327054804 | Formula | STRYKER CORPORATION | 2018-09-12 |
| 07613327054798 | Formula | STRYKER CORPORATION | 2018-09-12 |
| 07613327054781 | Formula | STRYKER CORPORATION | 2018-09-12 |
| 07613327054774 | Formula, Slap | STRYKER CORPORATION | 2018-09-12 |
| 07613327054767 | Formula | STRYKER CORPORATION | 2018-09-12 |
| 07613327054750 | Formula | STRYKER CORPORATION | 2018-09-12 |
| 07613327054743 | Formula | STRYKER CORPORATION | 2018-09-12 |
| 07613327054736 | Formula | STRYKER CORPORATION | 2018-09-12 |
| 07613327054729 | Formula | STRYKER CORPORATION | 2018-09-12 |
| 07613327054712 | Formula | STRYKER CORPORATION | 2018-09-12 |
| 07613327054705 | Formula | STRYKER CORPORATION | 2018-09-12 |
| 07613327054699 | Formula | STRYKER CORPORATION | 2018-09-12 |
| 07613153064824 | NA | STRYKER CORPORATION | 2016-09-23 |
| 07613153064909 | NA | STRYKER CORPORATION | 2016-09-23 |