FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody System
K Number: K242147
·
Decision Sep 20, 2024
Classifications
1
FEI Numbers
418
Registration Numbers
418
Same Product Code
890
Applicant Total
93
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
- Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody System
- K Number
- K242147
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3080
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Alphatec Spine, Inc.
- Date Received
- July 23, 2024
- Decision Date
- September 20, 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MAX), ordered by most recent decision date.
Fule Interbody Fusion Cage System
FDA 510(k)
FDA Class 2
·Orthopedic
Exceed® Biplanar Expandable Interbody System
FDA 510(k)
FDA Class 2
·Orthopedic
BMD Titanium Spinal Fusion System
FDA 510(k)
FDA Class 2
·Orthopedic
Ventana® P/T Lumbar Interbody System
FDA 510(k)
FDA Class 2
·Orthopedic
VersaLift Expandable System
FDA 510(k)
FDA Class 2
·Orthopedic
aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and transforaminal lumbar interbody system; aprevo® cervical interbody system; corra cervical plating system
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by Alphatec Spine, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K253615 | Invictus Bands System | Mar 25, 2026 | Substantially Equivalent |
| K252597 | Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with StealthStation) | Feb 19, 2026 | Substantially Equivalent |
| K252842 | SafeOp 3: Neural Informatix System | Jan 11, 2026 | Substantially Equivalent |
| K251965 | Proximity Anterior Cervical Plate System; Segmental Plating System (SPS) | Aug 28, 2025 | Substantially Equivalent |
| K251080 | IdentiTi II Cervical Interbody System | Jul 3, 2025 | Substantially Equivalent |
| K243461 | Calibrate Interbody Systems | Mar 4, 2025 | Substantially Equivalent |
| K242364 | IdentiTi II Interbody System | Oct 4, 2024 | Substantially Equivalent |
| K241519 | Invictus® Small Stature Spinal Fixation System | Jun 21, 2024 | Substantially Equivalent |
| K240199 | IntraOp Alignment System | May 22, 2024 | Substantially Equivalent |
| K234092 | SafeOp 3: Neural Informatix Systeem | Apr 19, 2024 | Substantially Equivalent |