FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BONE SAW BLADES
K Number: K931176
·
Decision Jan 26, 1994
Classifications
1
FEI Numbers
387
Registration Numbers
387
Same Product Code
75
Applicant Total
1
Review Days
323
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- BONE SAW BLADES
- K Number
- K931176
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4820
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Betzler Mfg., Inc.
- Date Received
- March 9, 1993
- Decision Date
- January 26, 1994
- Product Code
- HWE
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HWE | Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HWE), ordered by most recent decision date.
IntelliSense Drill
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
ORTHO SOLUTIONS - STERILE, DRILLS, TAPS, GUIDE PINS & WIRES
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
SURGICAL IRRIGATION SYSTEM, IRRIGATION TUBE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
EXPLANT OSTEONECROSIS INTERVENTION IMPLANT REMOVAL SYSTEM
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
SYNTHES (USA) ELECTRIC PEN DRIVE SYSTEM
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery