FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ANCHOR-L LUMBAR CAGE
K Number: K120869
·
Decision Oct 25, 2012
Classifications
1
FEI Numbers
254
Registration Numbers
254
Same Product Code
194
Applicant Total
64
Review Days
217
Basic Information
- Device Name
- ANCHOR-L LUMBAR CAGE
- K Number
- K120869
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3080
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- STRYKER SPINE
- Date Received
- March 22, 2012
- Decision Date
- October 25, 2012
- Product Code
- OVD
- 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 |
|---|---|---|---|
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | FDA class 2 | Orthopedic |
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