FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BIOFLEX
K Number: K072321
·
Decision Mar 25, 2008
Classifications
1
FEI Numbers
44
Registration Numbers
44
Same Product Code
21
Applicant Total
1
Review Days
218
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Basic Information
- Device Name
- BIOFLEX
- K Number
- K072321
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3070
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Biospine Co., Ltd.
- Date Received
- August 20, 2007
- Decision Date
- March 25, 2008
- Product Code
- NQP
- 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 |
|---|---|---|---|
| NQP | Posterior Metal/Polymer Spinal System, Fusion | FDA class 2 | Orthopedic |
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