FDA 510(k)
FDA class 2
Substantially Equivalent
🇯🇵 Japan
BIOACTIF OSTEOTRANS INTERFENCE SCREW
K Number: K081390
·
Decision Aug 12, 2008
Classifications
1
FEI Numbers
659
Registration Numbers
659
Same Product Code
1058
Applicant Total
6
Review Days
85
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Basic Information
- Device Name
- BIOACTIF OSTEOTRANS INTERFENCE SCREW
- K Number
- K081390
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Takiron Co., Ltd.
- Date Received
- May 19, 2008
- Decision Date
- August 12, 2008
- 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 Takiron Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K073006 | OSTEOTRANS -MX BIOABSORBABLE BONE FIXATION SYSTEM | May 29, 2008 | Substantially Equivalent |
| K073312 | OSTEOTRANS-OT SCREW | May 13, 2008 | Substantially Equivalent |
| K073311 | OSTEOTRANS-OT PIN | May 13, 2008 | Substantially Equivalent |
| K062691 | COMPORUS | Apr 15, 2008 | Substantially Equivalent |
| K061881 | OSTEOTRANS -MX BIOABSORBABLE BONE FIXATION SYSTEM | Mar 14, 2007 | Substantially Equivalent |