FDA.reportPublic FDA data

ORTHOCIRCLE

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30091320773009132077ORTHOCIRCLE1Y2026-01-016602 Abercorn St Ste 200 Savannah GA US 31405

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1291661514091500K222799Haymaker® Screw SystemHWC2023-01-10
1291661609594678K221172FOCUS Interbody SystemMAX2022-10-14
1291661644311576K193472OrthoCircle Spine Pedicle Screw SystemNKB2020-02-13

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
HWC12023-01-10
MAX12022-10-14
NKB12020-02-13