Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Alphatec Spine, Inc. — Predicate Candidate Screening
95 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
84 daysmedian FDA review time
158 days90th percentile
95clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261284 | Invictus® Small Stature Spinal Fixation System; Invictus® 2. | Alphatec Spine, Inc. | 2026-07-14 | 88 | 0 |
| K253216 | IntraOp Alignment System; CONTOUR3D Bending System | Alphatec Spine, Inc. | 2026-06-25 | 269 | 0 |
| K253615 | Invictus Bands System | Alphatec Spine, Inc. | 2026-03-25 | 127 | 0 |
| K252597 | Valence Robotic Navigation System; Valence Robotic Navigatio | Alphatec Spine, Inc. | 2026-02-19 | 188 | 0 |
| K252842 | SafeOp 3: Neural Informatix System | Alphatec Spine, Inc. | 2026-01-11 | 125 | 1 |
| K251965 | Proximity Anterior Cervical Plate System; Segmental Plating | Alphatec Spine, Inc. | 2025-08-28 | 63 | 0 |
| K251080 | IdentiTi II Cervical Interbody System | Alphatec Spine, Inc. | 2025-07-03 | 86 | 0 |
| K243461 | Calibrate Interbody Systems | Alphatec Spine, Inc. | 2025-03-04 | 116 | 0 |
| K242364 | IdentiTi™ II Interbody System | Alphatec Spine, Inc. | 2024-10-04 | 56 | 0 |
| K242147 | Calibrate LTX Interbody System; Calibrate NanoTec LTX Interb | Alphatec Spine, Inc. | 2024-09-20 | 59 | 0 |
| K241519 | Invictus® Small Stature Spinal Fixation System | Alphatec Spine, Inc. | 2024-06-21 | 23 | 0 |
| K240199 | IntraOp Alignment System | Alphatec Spine, Inc. | 2024-05-22 | 118 | 0 |
| K234092 | SafeOp 3: Neural Informatix Systeem | Alphatec Spine, Inc. | 2024-04-19 | 115 | 0 |
| K233640 | Segmental Plating System (SPS);IdentiTi SPS Interbody System | Alphatec Spine, Inc. | 2024-02-22 | 101 | 0 |
| K232345 | ATEC Posterior Navigated Disc Prep Instruments | Alphatec Spine, Inc. | 2023-11-02 | 90 | 0 |
| K232504 | Calibrate CCX Interbody System | Alphatec Spine, Inc. | 2023-10-13 | 56 | 1 |
| K232044 | Invictus Robotic Navigation Instruments | Alphatec Spine, Inc. | 2023-10-06 | 88 | 0 |
| K232173 | Ascend VBR System, Ascend NanoTec VBR System | Alphatec Spine, Inc. | 2023-10-06 | 77 | 0 |
| K232275 | Invictus® Spinal Fixation System | Alphatec Spine, Inc. | 2023-09-27 | 58 | 0 |
| K232097 | IdentiTi ALIF Interbody Systems | Alphatec Spine, Inc. | 2023-09-25 | 74 | 1 |
| K232413 | Fusion Robotic Navigation System | Alphatec Spine, Inc. | 2023-09-08 | 29 | 0 |
| K231438 | Calibrate PSX Interbody System, Calibrate NanoTec PSX Interb | Alphatec Spine, Inc. | 2023-07-13 | 57 | 0 |
| K230721 | ATEC Lateral Plate System | Alphatec Spine, Inc. | 2023-05-09 | 55 | 0 |
| K223611 | Calibrate LTX Interbody System | Alphatec Spine, Inc. | 2023-03-29 | 117 | 0 |
| K223765 | ATEC Lateral Navigation Instruments | Alphatec Spine, Inc. | 2023-03-23 | 98 | 2 |
| K221926 | Invictus® Bone Cement, Invictus Spinal Fixation System | Alphatec Spine, Inc. | 2022-12-20 | 172 | 0 |
| K222455 | Calibrate LTX Interbody System | Alphatec Spine, Inc. | 2022-11-18 | 95 | 0 |
| K222973 | IdentiTi and Transcend Interbody Systems: IndentiTi Cervical | Alphatec Spine, Inc. | 2022-11-17 | 50 | 0 |
| K221821 | ATEC IOM Accessory Instruments | Alphatec Spine, Inc. | 2022-09-23 | 92 | 0 |
| K220782 | IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Int | Alphatec Spine, Inc. | 2022-06-09 | 84 | 0 |
| K214006 | Invictus® Spinal Fixation System | Alphatec Spine, Inc. | 2022-04-04 | 103 | 0 |
| K213849 | SafeOp 2: Neural Informatix System | Alphatec Spine, Inc. | 2022-03-09 | 89 | 0 |
| K213443 | Insignia™ Anterior Cervical Plate System | Alphatec Spine, Inc. | 2021-12-15 | 51 | 0 |
| K213460 | Invictus Spinal Fixation System | Alphatec Spine, Inc. | 2021-12-10 | 44 | 0 |
| K211987 | ATEC Alignment App | Alphatec Spine, Inc. | 2021-10-29 | 123 | 0 |
| K211805 | IdentiTi Porous Ti Interbody System, Transcend PEEK Interbod | Alphatec Spine, Inc. | 2021-09-22 | 103 | 0 |
| K211873 | PSX Interbody System | Alphatec Spine, Inc. | 2021-08-10 | 54 | 0 |
| K203742 | IdentiTi ALIF Standalone Interbody System | Alphatec Spine, Inc. | 2021-04-09 | 108 | 0 |
| K203125 | Invictus™ OCT Spinal Fixation System | Alphatec Spine, Inc. | 2020-12-18 | 60 | 0 |
| K202812 | IdentiTi Cervical Standalone Interbody System | Alphatec Spine, Inc. | 2020-12-18 | 85 | 0 |
| K203056 | Invictus™ Spinal Fixation System | Alphatec Spine, Inc. | 2020-11-23 | 46 | 0 |
| K202587 | ATEC Lateral Interbody System | Alphatec Spine, Inc. | 2020-11-06 | 59 | 0 |
| K202327 | Invictus™ OsseoScrew® System | Alphatec Spine, Inc. | 2020-10-15 | 59 | 0 |
| K200936 | Invictus™ CT Spinal Fixation System | Alphatec Spine, Inc. | 2020-05-22 | 44 | 0 |
| K200995 | Insignia™ Anterior Cervical Plate System | Alphatec Spine, Inc. | 2020-05-21 | 35 | 0 |
| K192938 | Invictus™ Spinal Fixation System | Alphatec Spine, Inc. | 2019-12-12 | 55 | 0 |
| K191723 | ATEC IOM Accessory Instruments | Alphatec Spine, Inc. | 2019-10-18 | 113 | 0 |
| K191311 | ATEC Lateral Interbody System | Alphatec Spine, Inc. | 2019-08-12 | 89 | 0 |
| K182617 | ATEC IOM Accessory Instruments | Alphatec Spine, Inc. | 2019-05-09 | 227 | 0 |
| K183705 | IdentiTi Porous Ti Interbody System | Alphatec Spine, Inc. | 2019-03-01 | 60 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda