FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LEVTECH COMPOSITE TRACTION TONGS
K Number: K873693
·
Decision Feb 5, 1988
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
19
Applicant Total
5
Review Days
144
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
- LEVTECH COMPOSITE TRACTION TONGS
- K Number
- K873693
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5960
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- Levtech, Inc.
- Date Received
- September 14, 1987
- Decision Date
- February 5, 1988
- Product Code
- HAX
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| HAX | Tong, Skull For Traction | FDA class 2 | Neurology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HAX), ordered by most recent decision date.
PMT HALO SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
RESOLVE TONGS, SMALL/MEDIUM, RESOLVE TONGS, MEDIUM/LARGE, MODEL JT-200D, JT-100D
FDA 510(k)
FDA Class 2
·Neurology
RESOLVE OPEN BACK HALO RINGS
FDA 510(k)
FDA Class 2
·Neurology
JEROME GLASS RING
FDA 510(k)
FDA Class 2
·Neurology
SPINE WORKS COLLAR
FDA 510(k)
FDA Class 2
·Neurology
FRIDDLE HALO SYSTEM, FRIDDLE MRI HALO SYSTEM
FDA 510(k)
FDA Class 2
·Neurology