FDA 510(k)
FDA class 2
Substantially Equivalent
🇯🇵 Japan
OSTEOTRANS -MX BIOABSORBABLE BONE FIXATION SYSTEM
K Number: K073006
·
Decision May 29, 2008
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
41
Applicant Total
6
Review Days
218
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Basic Information
- Device Name
- OSTEOTRANS -MX BIOABSORBABLE BONE FIXATION SYSTEM
- K Number
- K073006
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5320
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Takiron Co., Ltd.
- Date Received
- October 24, 2007
- Decision Date
- May 29, 2008
- Product Code
- GWO
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| GWO | Plate, Cranioplasty, Preformed, Alterable | FDA class 2 | Neurology |
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Other Clearances by Takiron Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K081390 | BIOACTIF OSTEOTRANS INTERFENCE SCREW | Aug 12, 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 |