FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LIGAMENTOTAXOR
K Number: K094043
·
Decision Aug 17, 2010
Classifications
1
FEI Numbers
283
Registration Numbers
283
Same Product Code
203
Applicant Total
2
Review Days
229
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Basic Information
- Device Name
- LIGAMENTOTAXOR
- K Number
- K094043
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Arex USA
- Date Received
- December 31, 2009
- Decision Date
- August 17, 2010
- Product Code
- HTY
- 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 |
|---|---|---|---|
| HTY | Pin, Fixation, Smooth | FDA class 2 | Orthopedic |
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Other Clearances by Arex USA
| K Number | Device Name | ||
|---|---|---|---|
| K081011 | AREX SCRU 2 HEADLESS COMPRESSION SCREWS, MODELS: P2P10, P2P15, P2P20, P2P25, P2P30, P2P35, P2P40, P2P45 | Nov 7, 2008 | Substantially Equivalent |