FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
OSTEO-CABLE SLEEVE
K Number: K024022
·
Decision Jan 23, 2003
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
1
Applicant Total
441
Review Days
49
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Basic Information
- Device Name
- OSTEO-CABLE SLEEVE
- K Number
- K024022
- Device Class
- FDA class 1
- Clearance Type
- Special
- Regulation Number
- 888.4540
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Biomet, Inc.
- Date Received
- December 5, 2002
- Decision Date
- January 23, 2003
- Product Code
- HXN
- 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 |
|---|---|---|---|
| HXN | Applier, Cerclage | FDA class 1 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HXN), ordered by most recent decision date.
View allOther Clearances by Biomet, Inc.
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| K193546 | Distal Centralizers | Sep 25, 2020 | Substantially Equivalent |