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Recognized a 510(k)/PMA number — showing its clearance record and devices.

Clearance record K241375

IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi Cervical Porous Ti Interbody System; IdentiTi NanoTec Cervical Interbody System; IdentiTi Cervical Standalone Interbody System; IdentiTi NanoTec Cervical Standalone Interbody System; IdentiTi ALIF Standalone Interbody System; IdentiTi NanoTec ALIF Standalone Interbody System; Transcend PEEK Interbody System; Transcend NanoTec Interbody System; Transcend Cervical PEEK Interbody System; Transcend NanoTec Cer · Alphatec Spine · decided 2025-02-03 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
Transcend NanoTec310-PRO-09201612-SALPHATEC SPINE, INC.ODP00190376656045
Transcend NanoTec310-PRO-11181505-SALPHATEC SPINE, INC.ODP00190376656410
IdentiTi100-07185015-SALPHATEC SPINE, INC.MAX00190376566801
Transcend NanoTec310-PRO-09201512-SALPHATEC SPINE, INC.ODP00190376666563
Transcend NanoTec310-PRO-10161405-SALPHATEC SPINE, INC.ODP00190376656113
IdentiTi100-09184515-SALPHATEC SPINE, INC.MAX00190376566924
IdentiTi100-09184010-SALPHATEC SPINE, INC.MAX00190376566887
Transcend NanoTec310-PRO-07181607-SALPHATEC SPINE, INC.ODP00190376655499
IdentiTi100-11185500-SALPHATEC SPINE, INC.MAX00190376567112
Transcend NanoTec310-PRO-11181510-SALPHATEC SPINE, INC.ODP00190376656434
Transcend NanoTec310-PRO-09141207-SALPHATEC SPINE, INC.ODP00190376655826
IdentiTi100-11185015-SALPHATEC SPINE, INC.MAX00190376567105
Transcend NanoTec310-PRO-10201607-SALPHATEC SPINE, INC.ODP00190376656274
Transcend NanoTec310-PRO-09201610-SALPHATEC SPINE, INC.ODP00190376656038
Transcend NanoTec310-PRO-12161412-SALPHATEC SPINE, INC.ODP00190376656649
IdentiTi100-11184500-SALPHATEC SPINE, INC.MAX00190376567051
Transcend NanoTec310-PRO-10141215-SALPHATEC SPINE, INC.ODP00190376656106
Transcend NanoTec310-PRO-08181612-SALPHATEC SPINE, INC.ODP00190376655741
IdentiTi100-11185515-SALPHATEC SPINE, INC.MAX00190376567136
Transcend NanoTec310-PRO-10181510-SALPHATEC SPINE, INC.ODP00190376656182
Transcend NanoTec310-PRO-06181507-SALPHATEC SPINE, INC.ODP00190376655253
Transcend NanoTec140-PRO-09092220-SALPHATEC SPINE, INC.MAX PHM00190376700823
Transcend NanoTec310-PRO-12141215-SALPHATEC SPINE, INC.ODP00190376656601
Transcend NanoTec310-PRO-09181605-SALPHATEC SPINE, INC.ODP00190376655963
Transcend NanoTec310-PRO-05161407-SALPHATEC SPINE, INC.ODP00190376655093