FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
K&J IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage
K Number: K212038
·
Decision Aug 27, 2021
Classifications
1
FEI Numbers
339
Registration Numbers
339
Same Product Code
348
Applicant Total
2
Review Days
58
Basic Information
- Device Name
- K&J IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage
- K Number
- K212038
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3080
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- K&J Consulting Corporation
- Date Received
- June 30, 2021
- Decision Date
- August 27, 2021
- Product Code
- ODP
- 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 |
|---|---|---|---|
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | FDA class 2 | Orthopedic |
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Other Clearances by K&J Consulting Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K232877 | FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous Fixation System, and AEON-C Stand Alone System | Dec 13, 2023 | Substantially Equivalent |