FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
S & S ORTHOPEDIC WIRE DRIVER 701
K Number: K944488
·
Decision Mar 2, 1995
Classifications
1
FEI Numbers
81
Registration Numbers
81
Same Product Code
28
Applicant Total
1
Review Days
170
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
- S & S ORTHOPEDIC WIRE DRIVER 701
- K Number
- K944488
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4820
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- S & S Orthopedic , Ltd.
- Date Received
- September 13, 1994
- Decision Date
- March 2, 1995
- Product Code
- KIJ
- 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 |
|---|---|---|---|
| KIJ | Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KIJ), ordered by most recent decision date.
SMARTO
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
INSURGICAL SINGLE USE POWER EQUIPMENT
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
SMARTO
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
STRYKER SYSTEM 4000 HEAVY DUTY BATTERY POWERED EQUIPMENT
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
STRYKER 2115 REPLACEMENT BATTERY (2115)
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
ACUMED BONE GRAFT SYSTEM
FDA 510(k)
FDA Class 1
·General, Plastic Surgery