FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
prodisc C SK, prodisc C Nova, and prodisc C Vivo Instruments
K Number: K221848
·
Decision Aug 19, 2022
Classifications
1
FEI Numbers
9
Registration Numbers
9
Same Product Code
6
Applicant Total
3
Review Days
56
Basic Information
- Device Name
- prodisc C SK, prodisc C Nova, and prodisc C Vivo Instruments
- K Number
- K221848
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.4515
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Centinel Spine LLC
- Date Received
- June 24, 2022
- Decision Date
- August 19, 2022
- Product Code
- QLQ
- 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 |
|---|---|---|---|
| QLQ | Manual Instruments Designed For Use With Total Disc Replacement Devices | FDA class 2 | Orthopedic |
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