FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
REFIX PIN (PLLA), MODELS 2070L, 2770L, 3570L, 4570L; (PLGA), MODELS 2070LG, 2770LG, 3570LG, 4570LG
K Number: K043339
·
Decision Apr 18, 2005
Classifications
1
FEI Numbers
283
Registration Numbers
283
Same Product Code
203
Applicant Total
2
Review Days
136
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Basic Information
- Device Name
- REFIX PIN (PLLA), MODELS 2070L, 2770L, 3570L, 4570L; (PLGA), MODELS 2070LG, 2770LG, 3570LG, 4570LG
- K Number
- K043339
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Xtremi-T, LLC
- Date Received
- December 3, 2004
- Decision Date
- April 18, 2005
- 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 Xtremi-T, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K050388 | REFIX INTERNAL FRACTURE FIXATION SCREWS | Sep 7, 2005 | Substantially Equivalent |