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Data / Medical devices / United States / Maxmorespine

Maxmorespine: FDA-registered device maker in San Diego, CA, United States, 7 510(k) clearances

Maxmorespine is registered with the FDA (registration 3023155873) in San Diego, CA, United States. It lists 33 device types. The FDA files 7 510(k) clearances under its listings, the newest dated June 23, 2022. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number
3023155873
Address
8659 Production Ave. Suite A, San Diego, CA, United States, 92121
Owner or operator
Maxmorespine (10086790)
Roles
Complaint file establishment
First device listed
December 12, 2022
Registered through
2026
Brand names listed
BD Quincke Spinal Needle, Needle Placer, Tactile Ball Hook - 400mm, 2.5mm, maxmore Smart Pack System

Devices it lists

DeviceProduct codeClassRoleSource
Accessories, ArthroscopicNBH1Complaint file establishmentaccessdata.fda.gov
Accessories, Cleaning Brushes, For EndoscopeMNL1Complaint file establishmentaccessdata.fda.gov
ArthroscopeHRX2Complaint file establishmentaccessdata.fda.gov
Bit, DrillHTW1Complaint file establishmentaccessdata.fda.gov
Bit, SurgicalGFG1Complaint file establishmentaccessdata.fda.gov
Camera, Cine, Endoscopic, Without AudioFWL1Complaint file establishmentaccessdata.fda.gov
Cannula, Surgical, General & Plastic SurgeryGEA1Complaint file establishmentaccessdata.fda.gov
Chisel, Surgical, ManualFZO1Complaint file establishmentaccessdata.fda.gov
Curette, Surgical, General UseFZS1Complaint file establishmentaccessdata.fda.gov
Dam, RubberEIE1Complaint file establishmentaccessdata.fda.gov
Dissector, Surgical, General & Plastic SurgeryGDI1Complaint file establishmentaccessdata.fda.gov
Electrosurgical, Cutting & Coagulation & AccessoriesGEI2Complaint file establishmentaccessdata.fda.gov
Elevator, Surgical, General & Plastic SurgeryGEG1Complaint file establishmentaccessdata.fda.gov
ForcepsHTD1Complaint file establishmentaccessdata.fda.gov
Guide, Drill, LigamentLXI1Complaint file establishmentaccessdata.fda.gov
Guide, Needle, SurgicalGDF1Complaint file establishmentaccessdata.fda.gov
Guide, Surgical, InstrumentFZX1Complaint file establishmentaccessdata.fda.gov
Hammer, SurgicalFZY1Complaint file establishmentaccessdata.fda.gov
Holder, Needle; OrthopedicHXK1Complaint file establishmentaccessdata.fda.gov
Hook, Surgical, General & Plastic SurgeryGDG1Complaint file establishmentaccessdata.fda.gov
Knife, SurgicalEMF1Complaint file establishmentaccessdata.fda.gov
Motor, Surgical Instrument, Ac-PoweredGEY1Complaint file establishmentaccessdata.fda.gov
Needle, Conduction, Anesthetic (W/Wo Introducer)BSP2Complaint file establishmentaccessdata.fda.gov
Passer, Wire, OrthopedicHXI1Complaint file establishmentaccessdata.fda.gov
ProbeHXB1Complaint file establishmentaccessdata.fda.gov
Punch, SurgicalLRY1Complaint file establishmentaccessdata.fda.gov
ReamerHTO1Complaint file establishmentaccessdata.fda.gov
RetractorGAD1Complaint file establishmentaccessdata.fda.gov
Scissors, Orthopedic, SurgicalHRR1Complaint file establishmentaccessdata.fda.gov
Sterilization Wrap Containers, Trays, Cassettes & Other AccessoriesKCT2Complaint file establishmentaccessdata.fda.gov
Tape, Measuring, Rulers And CalipersFTY1Complaint file establishmentaccessdata.fda.gov
Tray, Surgical, InstrumentFSM1Complaint file establishmentaccessdata.fda.gov
WrenchHXC1Complaint file establishmentaccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
June 23, 2022K211173maxmorespine Bipolar ElectrodesGEISubstantially EquivalentHoogland Spine Products, GmbHaccessdata.fda.gov
December 22, 2021K210978BD Quincke Spinal Needle, BD Whitacre Spinal Needle, BD Spinal Introducer NeedleBSPSubstantially EquivalentBecton, Dickinson and Companyaccessdata.fda.gov
September 29, 2020K193131BD Quincke Spinal NRFit Needle, BD Whitacre Spinal NRFit Needle, BD Spinal Introducer NRFit NeedleBSPSubstantially EquivalentBecton, Dickinson and Companyaccessdata.fda.gov
April 16, 2012K120117CODMAN QUAD-LOCK STERILIZATION CONTAINER SYSTEMKCTSubstantially EquivalentCodman & Shurtleff, Inc.accessdata.fda.gov
October 9, 2009K083552MAXMORESPINE TOM STICKHRXSubstantially EquivalentHoogland Spine Products, GmbHaccessdata.fda.gov
June 9, 2009K090132MAXMORESPINE SPINAL SYSTEMHRXSubstantially EquivalentHoogland Spine Products, GmbHaccessdata.fda.gov
January 20, 1987K864402BIPOLAR ELECTROSURGICAL INTRAOCULAR PROBEGEISubstantially EquivalentNew England Surgical Instrument Corp.accessdata.fda.gov

Compare with other makers

Updated June 23, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.