FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
KLEIN WIRE TIGHTENER/BIONIC WIRE
K Number: K833726
·
Decision Dec 22, 1983
Classifications
1
FEI Numbers
117
Registration Numbers
117
Same Product Code
1
Applicant Total
1
Review Days
59
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Basic Information
- Device Name
- KLEIN WIRE TIGHTENER/BIONIC WIRE
- K Number
- K833726
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 888.4540
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- Bionic Instrument Corp.
- Date Received
- October 24, 1983
- Decision Date
- December 22, 1983
- Product Code
- HXS
- Advisory Committee
- Orthopedic
- 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 |
|---|---|---|---|
| HXS | Twister, Wire | FDA class 1 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HXS), ordered by most recent decision date.
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