C-BLADE
FDA 510(k) clearance K802105 · decided 1980-09-16
Clearance details
- K-number
- K802105
- Device name
- C-BLADE
- Applicant
- Cutter Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1980-09-03
- Decision date
- 1980-09-16
- Days to decision
- 13 days
- Clearance type
- Traditional
- Product code
- HWE
- Device class
- 1
- Regulation number
- 878.4820
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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| Record | Firm | Date |
|---|---|---|
| IntelliSense Drill (K143191) | Mcginley Innovations | 2015-02-20 |
| ORTHO SOLUTIONS - STERILE, DRILLS, TAPS, GUIDE PINS & WIRES (K102743) | Ortho Solutions Limited | 2011-01-20 |
| SURGICAL IRRIGATION SYSTEM, IRRIGATION TUBE (K063688) | The Anspach Effort, Inc. | 2007-01-16 |
| EXPLANT OSTEONECROSIS INTERVENTION IMPLANT REMOVAL SYSTEM (K050766) | Zimmer Trabecular | 2005-05-26 |
| SYNTHES (USA) ELECTRIC PEN DRIVE SYSTEM (K043310) | Synthes (Usa) | 2005-01-05 |
| REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURS (K022744) | Medical Device Services | 2002-09-18 |
| REPROCESSED USED, DISPOSABLE BLADES, BURS, BITS AND TAPS (K012676) | Adven Medical | 2002-02-04 |
| REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURS (K012694) | Adven Medical | 2002-02-04 |
| AVCORE SYSTEM (K990816) | Modular Cutting Systems, Inc. | 1999-09-24 |
| AESCULAP HILAN MOTOR SYSTEM (K973736) | Aesculap, Inc. | 1997-12-29 |
| BONE GRAFT HARVESTER (K973560) | Ds Mfg., Inc. | 1997-11-12 |
| SURGICAL BURS AND SURGICAL DRILL BITS (K972508) | Synvasive Technology, Inc. | 1997-08-26 |
Recalls involving this device
No recalls on record reference this clearance.