FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RAPIDFLAP LS CRANIAL FLAP FIXATION SYSTEM
K Number: K130309
·
Decision Jun 17, 2013
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
28
Applicant Total
25
Review Days
130
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- RAPIDFLAP LS CRANIAL FLAP FIXATION SYSTEM
- K Number
- K130309
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5250
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Biomet Microfixation
- Date Received
- February 7, 2013
- Decision Date
- June 17, 2013
- Product Code
- GXR
- 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 |
|---|---|---|---|
| GXR | Cover, Burr Hole | FDA class 2 | Neurology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GXR), ordered by most recent decision date.
Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover)
FDA 510(k)
FDA Class 2
·Neurology
Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation System
FDA 510(k)
FDA Class 2
·Neurology
Absorbable Cranial Flap Fixation System
FDA 510(k)
FDA Class 2
·Neurology
Flap Fixator, Burr Hole Cover
FDA 510(k)
FDA Class 2
·Neurology
NeuroVention Cranial Fixation System, NuCrani Plates, KTC Burr Hole Cover, DC Plate
FDA 510(k)
FDA Class 2
·Neurology
OSSDSIGN Cranioplug
FDA 510(k)
FDA Class 2
·Neurology
Other Clearances by Biomet Microfixation
| K Number | Device Name | ||
|---|---|---|---|
| K261002 | Pectus Blu System | Jun 2, 2026 | Substantially Equivalent |
| 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 |