FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
KLIMT Expandable Lumbar Interbody Fusion (LIF) Cage System
K Number: K233947
·
Decision Oct 10, 2024
Classifications
1
FEI Numbers
418
Registration Numbers
418
Same Product Code
890
Applicant Total
14
Review Days
301
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Basic Information
- Device Name
- KLIMT Expandable Lumbar Interbody Fusion (LIF) Cage System
- K Number
- K233947
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3080
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ctl Medical Corporation
- Date Received
- December 14, 2023
- Decision Date
- October 10, 2024
- Product Code
- MAX
- 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 |
|---|---|---|---|
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | FDA class 2 | Orthopedic |
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Other Clearances by Ctl Medical Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K231715 | MONDRIAN Anterior Lumbar Plate System | Jan 26, 2024 | Substantially Equivalent |
| K231359 | RODIN Expandable Lumbar Cage System | Jun 9, 2023 | Substantially Equivalent |
| K220513 | NITRO Interbody Fusion Cage System Family | Apr 25, 2023 | Substantially Equivalent |
| K220334 | MONET Anterior Cervical Plate System | Nov 9, 2022 | Substantially Equivalent |
| K211785 | CASSATT SIJ Fixation System | Oct 17, 2022 | Substantially Equivalent |
| K213641 | MONDRIAN ALIF Cage with Supplementary Fixation Plate | Sep 15, 2022 | Substantially Equivalent |
| K213491 | Universal Pilot Guidance Instrument System | May 12, 2022 | Substantially Equivalent |
| K192863 | MONDRIAN Lumbar Interbody Fusion Cage System | Aug 26, 2020 | Substantially Equivalent |
| K182151 | MONET Anterior Cervical Interbody Fusion Cage System with Supplementary Fixation Plate | Oct 11, 2018 | Substantially Equivalent |
| K172788 | MONET Anterior Cervical Interbody Fusion Cage System | Jun 25, 2018 | Substantially Equivalent |