FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Pectus Blu System
K Number: K261002
·
Decision Jun 2, 2026
Classifications
1
FEI Numbers
519
Registration Numbers
519
Same Product Code
1313
Applicant Total
25
Review Days
68
Basic Information
- Device Name
- Pectus Blu System
- K Number
- K261002
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Biomet Microfixation
- Date Received
- March 26, 2026
- Decision Date
- June 2, 2026
- Product Code
- HRS
- 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 |
|---|---|---|---|
| HRS | Plate, Fixation, Bone | FDA class 2 | Orthopedic |
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Other Clearances by Biomet Microfixation
| K Number | Device Name | ||
|---|---|---|---|
| K241709 | Pectus Blu Support Bar System | Sep 19, 2024 | Substantially Equivalent |
| 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 |
| K163007 | Biomet Microfixation SternaLock 360 Sternal Closure System | Nov 23, 2016 | Substantially Equivalent |