FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LEVTECH BONE SCREW
K Number: K901144
·
Decision Oct 10, 1990
Classifications
1
FEI Numbers
659
Registration Numbers
659
Same Product Code
1058
Applicant Total
5
Review Days
212
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Basic Information
- Device Name
- LEVTECH BONE SCREW
- K Number
- K901144
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- Levtech, Inc.
- Date Received
- March 12, 1990
- Decision Date
- October 10, 1990
- Product Code
- HWC
- 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 |
|---|---|---|---|
| HWC | Screw, Fixation, Bone | FDA class 2 | Orthopedic |
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Other Clearances by Levtech, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K910128 | LEVTECH TITANIUM BONE WIRE | Jun 18, 1991 | Substantially Equivalent |
| K873693 | LEVTECH COMPOSITE TRACTION TONGS | Feb 5, 1988 | Substantially Equivalent |
| K874023 | LEVTECH CLAMP APPLIER | Nov 6, 1987 | Substantially Equivalent |
| K850039 | HALIFAX SPINAL CLAMP | May 29, 1985 | Substantially Equivalent |