FDA.report

restor3d, inc.

Matched from indexed company URL: Restor3d, Inc.

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
30148337503014833750restor3d, inc.1N2026-01-014001 NC Hwy 54, Suite 2160 Durham NC US 27709

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2212341438415636K253992Veritas Reverse Total Shoulder SystemPHX2026-05-07
2212341865023840K252067Velora Acetabular SystemLPH2025-12-05
2212341409545423K243768iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement SystemMBH2025-03-27
2212341429695035K243643restor3d Reverse Total Shoulder Arthroplasty SystemPHX2025-05-19
2212341051748514K242868Kinos Total Ankle SystemHSN2024-10-18
2212341473416048K242356TIDAL Fusion Cage SystemSAI2025-03-24
2212341247445063K240591restor3d Kinos Axiom Total Ankle SystemHSN2024-04-29
2212341578144337K234087restor3d TIDAL Lumbar Interbody Fusion SystemMAX2024-01-22
2212341044922042K232595Kinos Axiom Total Ankle SystemHSN2023-11-28
2212341356853260K223326Axiom PSR SystemOYK2023-03-30
2212341016337343K220523restor3d TiDAL Lumbar Interbody Fusion DeviceMAX2022-06-17
2212341688688179K211789restor3d Pin ImplantsHTY2022-01-04
2212341377045863K201393restor3d MTP ImplantKWD2022-05-25
2212341160107884K201314Restor3d Utility WedgePLF2021-06-17
2212341928761967K192778Kinos Axiom Total Ankle SystemHSN2020-06-30
2212341709353069K191812ADI Cervical Interbody Fusion DeviceODP2019-10-24
2212341450586696K191047ADI TiDAL Osteotomy WedgePLF2019-11-05
2212341969573603H230003
2212341166511247
2212341912703097
2212342029992237

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
HSN42024-10-18
PHX22026-05-07
MAX22024-01-22
PLF22021-06-17
LPH12025-12-05
MBH12025-03-27
SAI12025-03-24
OYK12023-03-30
KWD12022-05-25
HTY12022-01-04
ODP12019-10-24

PMA

PMN

Applications

GUDID