FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Biomet Microfixation RibFix Blu Thoracic Fixation System
K Number: K151173
·
Decision May 26, 2015
Classifications
1
FEI Numbers
659
Registration Numbers
659
Same Product Code
1058
Applicant Total
25
Review Days
25
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Basic Information
- Device Name
- Biomet Microfixation RibFix Blu Thoracic Fixation System
- K Number
- K151173
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Biomet Microfixation
- Date Received
- May 1, 2015
- Decision Date
- May 26, 2015
- 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 Biomet Microfixation
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|---|---|---|---|
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| K223199 | 2.1 x 255mm Drill, 22mm Stop | Nov 15, 2022 | Substantially Equivalent |
| K212782 | SternaLock Sternal Closure System | May 17, 2022 | Substantially Equivalent |
| K212608 | RibFix Blu Thoracic Fixation System | Apr 22, 2022 | Substantially Equivalent |
| K213712 | Pectus Support Bar System | Mar 11, 2022 | Substantially Equivalent |
| K213208 | Twist Drills | Dec 23, 2021 | Substantially Equivalent |
| K202969 | Biomet Microfixation OmniMax MMF System | Aug 5, 2021 | Substantially Equivalent |
| K190576 | WalterLorenz Surgical Assist Arm Scope Holder | Jun 5, 2019 | Substantially Equivalent |
| K162974 | Biomet Microfixation RibFix Blu Thoracic Fixation System | Dec 9, 2016 | Substantially Equivalent |