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 |
| 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 |
|---|---|---|---|
| 10886982131225 | NA | Synthes GmbH | 2016-12-31 |
| 10886982239013 | NA | Synthes GmbH | 2016-12-31 |
| 10886982238979 | NA | Synthes GmbH | 2016-12-31 |
| 10886982238962 | NA | Synthes GmbH | 2016-12-31 |
| 10886982131546 | NA | Synthes GmbH | 2016-12-31 |
| 10886982131508 | NA | Synthes GmbH | 2016-12-31 |
| 10886982131485 | NA | Synthes GmbH | 2016-12-31 |
| 10886982131447 | NA | Synthes GmbH | 2016-12-31 |
| 10886982131423 | NA | Synthes GmbH | 2016-12-31 |
| 10886982131409 | NA | Synthes GmbH | 2016-12-31 |
| 10886982131362 | NA | Synthes GmbH | 2016-12-31 |
| 10886982131348 | NA | Synthes GmbH | 2016-12-31 |
| 10886982131300 | NA | Synthes GmbH | 2016-12-31 |
| 10886982131287 | NA | Synthes GmbH | 2016-12-31 |
| 10886982131249 | NA | Synthes GmbH | 2016-12-31 |
| 10886982130761 | NA | Synthes GmbH | 2016-12-31 |
| 10886982131164 | NA | Synthes GmbH | 2016-12-31 |
| 10886982131140 | NA | Synthes GmbH | 2016-12-31 |
| 10886982131102 | NA | Synthes GmbH | 2016-12-31 |
| 10886982131089 | NA | Synthes GmbH | 2016-12-31 |
| 10886982131041 | NA | Synthes GmbH | 2016-12-31 |
| 10886982131027 | NA | Synthes GmbH | 2016-12-31 |
| 10886982131003 | NA | Synthes GmbH | 2016-12-31 |
| 10886982130969 | NA | Synthes GmbH | 2016-12-31 |
| 10886982130945 | NA | Synthes GmbH | 2016-12-31 |
| 10886982130907 | NA | Synthes GmbH | 2016-12-31 |
| 10886982130884 | NA | Synthes GmbH | 2016-12-31 |
| 10886982130846 | NA | Synthes GmbH | 2016-12-31 |
| 10886982130822 | NA | Synthes GmbH | 2016-12-31 |
| 10886982130808 | NA | Synthes GmbH | 2016-12-31 |