FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Statera-C Spinal System
K Number: K233332
·
Decision Nov 27, 2023
Classifications
1
FEI Numbers
143
Registration Numbers
143
Same Product Code
112
Applicant Total
3
Review Days
59
Basic Information
- Device Name
- Statera-C Spinal System
- K Number
- K233332
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3075
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- K&J Consulting Corp.
- Date Received
- September 29, 2023
- Decision Date
- November 27, 2023
- Product Code
- NKG
- 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 |
|---|---|---|---|
| NKG | Posterior Cervical Screw System | FDA class 2 | Orthopedic |
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Other Clearances by K&J Consulting Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K232586 | Rexious Spinal Fixation System, Statera Spinal System, Statera-M Spinal System | Oct 24, 2023 | Substantially Equivalent |
| K231460 | FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, BALTEUM & BALTEUM-ONE Lumbar Plate System, and Osprey Anterior Cervical Plate System | Jul 16, 2023 | Substantially Equivalent |