FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SPEEDLOCK HIP KNOTLESS FIXATION IMPLANT
K Number: K123240
·
Decision Feb 14, 2013
Classifications
1
FEI Numbers
275
Registration Numbers
275
Same Product Code
593
Applicant Total
37
Review Days
121
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Basic Information
- Device Name
- SPEEDLOCK HIP KNOTLESS FIXATION IMPLANT
- K Number
- K123240
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- ArthroCare Corporation
- Date Received
- October 16, 2012
- Decision Date
- February 14, 2013
- Product Code
- MBI
- 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 |
|---|---|---|---|
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | FDA class 2 | Orthopedic |
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