FDA.reportPublic FDA data

CALVARY SPINE, LLC

Matched from indexed company URL: CALVARY SPINE LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30072798453007279845CALVARY SPINE, LLC1N2026-01-01308 North Wind Rd. Towson MD US 21204

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
B114120000Lumbar Spacer Inserter - Inserter used for lumbar inter-vertebral body spacer placement786-301-8006james.r.edw@gmail.com
B114213000Cervical Spacer Inserter - Inserter used for cervical inter-vertebral body spacer placement786-301-8006james.r.edw@gmail.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
958171462481530K201568Calvary Spine Pedicle Screw SystemNKB2020-11-12
958171220772885K082260INTEGRA CERVICAL AND PETRA PLIF LUMBAR CAGESMAX2008-10-17
958172043533395

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NKB12020-11-12
MAX12008-10-17

PMN#

GUDID#

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