FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
prodisc® L Instruments
K Number: K250554
·
Decision Apr 25, 2025
Classifications
1
FEI Numbers
11
Registration Numbers
11
Same Product Code
7
Applicant Total
3
Review Days
59
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Basic Information
- Device Name
- prodisc® L Instruments
- K Number
- K250554
- 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
- February 25, 2025
- Decision Date
- April 25, 2025
- 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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