FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IntraOp Alignment System
K Number: K240199
·
Decision May 22, 2024
Classifications
1
FEI Numbers
118
Registration Numbers
118
Same Product Code
319
Applicant Total
93
Review Days
118
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
- IntraOp Alignment System
- K Number
- K240199
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1650
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Alphatec Spine, Inc.
- Date Received
- January 25, 2024
- Decision Date
- May 22, 2024
- Product Code
- OWB
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- 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 |
|---|---|---|---|
| OWB | Interventional Fluoroscopic X-Ray System | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (OWB), ordered by most recent decision date.
C-beam
FDA 510(k)
FDA Class 2
·Radiology
Intelligent NR
FDA 510(k)
FDA Class 2
·Radiology
ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS pheno
FDA 510(k)
FDA Class 2
·Radiology
ARTIS genio floor; ARTIS icono.explore floor
FDA 510(k)
FDA Class 2
·Radiology
BELLIGER ACE
FDA 510(k)
FDA Class 2
·Radiology
Trinias
FDA 510(k)
FDA Class 2
·Radiology
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 |
| K242147 | Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody System | Sep 20, 2024 | Substantially Equivalent |
| K241519 | Invictus® Small Stature Spinal Fixation System | Jun 21, 2024 | Substantially Equivalent |
| K234092 | SafeOp 3: Neural Informatix Systeem | Apr 19, 2024 | Substantially Equivalent |