FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RHAUSLER PLAGE ANTERIOR CERVICAL FUSION SYSTEM
K Number: K111272
·
Decision Nov 29, 2011
Classifications
1
FEI Numbers
230
Registration Numbers
230
Same Product Code
161
Applicant Total
2
Review Days
209
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Basic Information
- Device Name
- RHAUSLER PLAGE ANTERIOR CERVICAL FUSION SYSTEM
- K Number
- K111272
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 888.3080
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Rhausler, Inc.
- Date Received
- May 4, 2011
- Decision Date
- November 29, 2011
- Product Code
- OVE
- 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 |
|---|---|---|---|
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | FDA class 2 | Orthopedic |
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Other Clearances by Rhausler, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K150455 | RT2 Trabeculite Titanium Cervical Cage System | Nov 19, 2015 | Substantially Equivalent |