FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
M6-C Single Use, Disposable Instrumentation
K Number: K241117
·
Decision Jun 21, 2024
Classifications
1
FEI Numbers
11
Registration Numbers
11
Same Product Code
7
Applicant Total
1
Review Days
59
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- M6-C Single Use, Disposable Instrumentation
- K Number
- K241117
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.4515
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Spinal Kinetics / Orthofix / Seaspine
- Date Received
- April 23, 2024
- Decision Date
- June 21, 2024
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (QLQ), ordered by most recent decision date.
Synergy Disc Instruments
FDA 510(k)
FDA Class 2
·Orthopedic
prodisc® L Instruments
FDA 510(k)
FDA Class 2
·Orthopedic
prodisc® L Instruments
FDA 510(k)
FDA Class 2
·Orthopedic
activL® Next Generation Instrumentation
FDA 510(k)
FDA Class 2
·Orthopedic
prodisc C SK, prodisc C Nova, and prodisc C Vivo Instruments
FDA 510(k)
FDA Class 2
·Orthopedic
M6-C Artificial Cervical Disc Instruments AS
FDA 510(k)
FDA Class 2
·Orthopedic