FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IdentiTi Porous Ti Interbody System, IdentiTi NanoTec Interbody System, Transcend PEEK Interbody System, Transcend NanoTec Interbody System, IdentiTi ALIF Standalone Interbody System, IdentiTi NanoTec ALIF Standalone Interbody System, IdentiTi Cervical Standalone Interbody System, IdentiTi NanoTec Cervical Standalone Interbody System
K Number: K220782
·
Decision Jun 9, 2022
Classifications
1
FEI Numbers
418
Registration Numbers
418
Same Product Code
890
Applicant Total
93
Review Days
84
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Basic Information
- Device Name
- IdentiTi Porous Ti Interbody System, IdentiTi NanoTec Interbody System, Transcend PEEK Interbody System, Transcend NanoTec Interbody System, IdentiTi ALIF Standalone Interbody System, IdentiTi NanoTec ALIF Standalone Interbody System, IdentiTi Cervical Standalone Interbody System, IdentiTi NanoTec Cervical Standalone Interbody System
- K Number
- K220782
- 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
- March 17, 2022
- Decision Date
- June 9, 2022
- 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
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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
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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 |
| K240199 | IntraOp Alignment System | May 22, 2024 | Substantially Equivalent |