Atlas FDA

IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System, IdentiTi NanoTec Cervical Interbody System, Transcend Cervical PEEK Interbody System, Transcend NanoTec Cervical Interbody System, IdentiTi Cervical Standalone Interbody System, IdentiTi NanoTec Cervical Standalone Interbody Sytem

FDA 510(k) clearance K222973 · decided 2022-11-17

Clearance details

K-number
K222973
Device name
IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System, IdentiTi NanoTec Cervical Interbody System, Transcend Cervical PEEK Interbody System, Transcend NanoTec Cervical Interbody System, IdentiTi Cervical Standalone Interbody System, IdentiTi NanoTec Cervical Standalone Interbody Sytem
Applicant
Alphatec Spine, Inc.
Decision
Substantially Equivalent
Date received
2022-09-28
Decision date
2022-11-17
Days to decision
50 days
Clearance type
Traditional
Product code
ODP
Device class
2
Regulation number
888.3080
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Carlsbad, CA, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
3d Cage Cervical (K253041)Fims Co., Ltd.2026-07-23
Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior Lumbar Cage; Aero® -C Cervical Cage System; AVS® Anchor-C Cervical Cage System; AVS® TL PEEK Spacer; AVS® PL PEEK Spacers; AVS® Navigator PEEK Spacer; AVS® AS PEEK Spacer; Monterey™ AL Interbody System; Aleutian IBF System; Cascadia Interbody System; Chesapeake Stabilization System; Sahara Stabilization System; SANTORINI™ Corpectomy Cage System; MOJAVE Interbody System; VLIFT VERTEBRAL BODY REPLACEM (K262061)Stryker Spine2026-07-17
C.A. Medical Interbody Fusion System (K254130)C.A. Medical, LLC2026-07-08
BluEX Cervical Expandable Cage System (K260840)L&K BIOMED Co., Ltd.2026-05-16
OSTEOMNI SPINAL CAGES SYSTEM (K260850)Osteomni, Inc.2026-05-12
ZSFab Cervical Interbody System and ZSFab Lumbar Interbody System (K260549)Zsfab, Inc.2026-04-24
ORIO-3D Cage System (K253260)SpineCraft2026-04-16
HC BIOLOGICS OSTEOPOINT PEEK CAGES, HC BIOLOGICS OSTEOPOINT CERVICAL PEEK CAGES, HC BIOLOGICS OSTEOPOINT LUMBAR PEEK CAGES (K260340)HC Biologics, LLC2026-04-13
MOD-C (K242303)Orthomod, LLC2026-04-01
Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage System (K252240)Spectrum Spine2026-03-30
Flex-Z™ Cervical Cage (K252432)Spinepoint, LLC2026-03-25
Hive™ Standalone Cervical System and Hive™ C Interbody System (K254105)NanoHive Medical, LLC2026-02-13

Recalls involving this device

No recalls on record reference this clearance.