FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RxG Distraction System
K Number: K150771
·
Decision Aug 27, 2015
Classifications
1
FEI Numbers
9
Registration Numbers
9
Same Product Code
5
Applicant Total
20
Review Days
156
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Basic Information
- Device Name
- RxG Distraction System
- K Number
- K150771
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5330
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- KLS Martin L.P.
- Date Received
- March 24, 2015
- Decision Date
- August 27, 2015
- Product Code
- PBJ
- 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 |
|---|---|---|---|
| PBJ | Cranial Distraction System | FDA class 2 | Neurology |
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