FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FRACTURE/RECONSTRUCTION SYSTEM (TRAUMAONE)
K Number: K081067
·
Decision May 9, 2008
Classifications
1
FEI Numbers
106
Registration Numbers
106
Same Product Code
291
Applicant Total
5
Review Days
24
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Basic Information
- Device Name
- FRACTURE/RECONSTRUCTION SYSTEM (TRAUMAONE)
- K Number
- K081067
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 872.4760
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Biomet Microfixation, Inc.
- Date Received
- April 15, 2008
- Decision Date
- May 9, 2008
- Product Code
- JEY
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- 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 |
|---|---|---|---|
| JEY | Plate, Bone | FDA class 2 | Dental |
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Other Clearances by Biomet Microfixation, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K111908 | BIOMET MICROFIXATION STERNAL CLOSURE SYSTEM | Nov 29, 2011 | Substantially Equivalent |
| K110574 | BIOMET MICROFIXATION STERNALOCK BLU STERNAL CLOSURE SYSTEM | May 18, 2011 | Substantially Equivalent |
| K091058 | ADKINS STRUT | Jul 22, 2009 | Substantially Equivalent |
| K071577 | BIOMET MICROFIXATION LACTOSORB PECTUS STABILIZER | Sep 6, 2007 | Substantially Equivalent |