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Data / Medical devices / United States / Camber Spine Technologies

Camber Spine Technologies: FDA-registered device maker in King of Prussia, PA, United States, 34 510(k) clearances

Camber Spine Technologies is registered with the FDA (registration 3010197239) in King of Prussia, PA, United States. It lists 34 device types. The FDA files 34 510(k) clearances under its listings, the newest dated July 12, 2024. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch Camber Spine Technologies
FDA registration number
3010197239
Address
501 Allendale Rd, King of Prussia, PA, United States, 19406
Owner or operator
Camber Spine/Medical Technologies (10043961)
Roles
Complaint file establishment, Manufacturer, Manufacturer for export, Repackager or relabeler, Specification developer
First device listed
April 11, 2013
Registered through
2026
Brand names listed
ALTIVO Anterior Cervical Fixation System, Alcantara Thoracolumbar Plate System, Aspiration needle, Awl, BIA-GEN, Bone Buddies Bone Harvester, Bone Tap, Caliper and more

Devices it lists

DeviceProduct codeClassRoleSource
Appliance, Fixation, Spinal Intervertebral BodyKWQ2Complaint file establishment, Manufacturer, Specification developeraccessdata.fda.gov
AwlHWJ1Complaint file establishment, Specification developeraccessdata.fda.gov
Bit, DrillHTW1Complaint file establishment, Specification developeraccessdata.fda.gov
CaliperKTZ1Complaint file establishment, Specification developeraccessdata.fda.gov
Camera, Surgical And AccessoriesKQM1Specification developeraccessdata.fda.gov
Chisel, Surgical, ManualFZO1Complaint file establishment, Specification developeraccessdata.fda.gov
CuretteHTF1Complaint file establishment, Specification developeraccessdata.fda.gov
Filler, Bone Void, Calcium CompoundMQV2Repackager or relabeleraccessdata.fda.gov
Gauge, DepthHTJ1Complaint file establishment, Specification developeraccessdata.fda.gov
Guide, Surgical, InstrumentFZX1Complaint file establishment, Specification developeraccessdata.fda.gov
Hammer, SurgicalFZY1Complaint file establishment, Specification developeraccessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, CervicalODP2Complaint file establishment, Manufacturer, Specification developeraccessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, LumbarMAX2Complaint file establishment, Manufacturer, Manufacturer for export, Repackager or relabeler, Specification developeraccessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, ThoracicPHM2Specification developeraccessdata.fda.gov
Intervertebral Fusion Device With Integrated Fixation, CervicalOVE2Complaint file establishment, Manufacturer, Specification developeraccessdata.fda.gov
Intervertebral Fusion Device With Integrated Fixation, LumbarOVD2Complaint file establishment, Specification developeraccessdata.fda.gov
MalletHXL1Complaint file establishment, Specification developeraccessdata.fda.gov
Needle, Aspiration And Injection, ReusableGDM1Complaint file establishment, Specification developeraccessdata.fda.gov
Orthopedic Manual Surgical InstrumentLXH1Complaint file establishment, Repackager or relabeler, Specification developeraccessdata.fda.gov
Orthopedic Stereotaxic InstrumentOLO2Complaint file establishment, Specification developeraccessdata.fda.gov
Orthosis, Spinal Pedicle FixationMNI2Complaint file establishment, Specification developeraccessdata.fda.gov
Orthosis, Spondylolisthesis Spinal FixationMNH2Complaint file establishment, Specification developeraccessdata.fda.gov
ProbeHXB1Complaint file establishment, Specification developeraccessdata.fda.gov
RaspHTR1Complaint file establishment, Specification developeraccessdata.fda.gov
RetractorGAD1Complaint file establishment, Specification developeraccessdata.fda.gov
RongeurHTX1Complaint file establishment, Specification developeraccessdata.fda.gov
ScrewdriverHXX1Complaint file establishment, Specification developeraccessdata.fda.gov
Spinal Vertebral Body Replacement DeviceMQP2Complaint file establishment, Repackager or relabeler, Specification developeraccessdata.fda.gov
Syringe, PistonFMF2Complaint file establishment, Specification developeraccessdata.fda.gov
System, X-Ray, Film Marking, RadiographicJAC1Complaint file establishment, Specification developeraccessdata.fda.gov
TampHXG1Complaint file establishment, Specification developeraccessdata.fda.gov
Tap, BoneHWX1Complaint file establishment, Specification developeraccessdata.fda.gov
Thoracolumbosacral Pedicle Screw SystemNKB2Complaint file establishment, Specification developeraccessdata.fda.gov
Tray, Surgical, InstrumentFSM1Complaint file establishment, Specification developeraccessdata.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
July 12, 2024K234077SPIRA® Anterior Lumbar SpacersMAXSubstantially EquivalentCamber Spine Technologiesaccessdata.fda.gov
April 16, 2024K232256Alcantara Thoracolumbar Plate SystemKWQSubstantially EquivalentCamber Spine Technologies, LLCaccessdata.fda.gov
July 11, 2023K230942SPIRA® Posterior Lumbar SpacersMAXSubstantially EquivalentCamber Spine Technologiesaccessdata.fda.gov
March 30, 2023K221324ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)OVDSubstantially EquivalentCamber Spine Technologiesaccessdata.fda.gov
March 22, 2023K223837SPIRA®-C Integrated Fixation SystemOVESubstantially EquivalentCamber Spine Technologiesaccessdata.fda.gov
April 29, 2022K220038Camber Spine Navigation SystemOLOSubstantially EquivalentCamber Spine Technologiesaccessdata.fda.gov
June 15, 2021K210595SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar SpacersMAXSubstantially EquivalentCamber Spine Technologies, LLCaccessdata.fda.gov
April 24, 2020K193153SPIRA-C Integrated Fixation SystemOVESubstantially EquivalentCamber Spine Technologiesaccessdata.fda.gov
October 22, 2019K191584FORTICO Anterior Cervical Fixation SystemKWQSubstantially EquivalentCamber Spine Technologies, LLCaccessdata.fda.gov
September 23, 2019K190483SPIRA Open Matrix ALIF and LLIFMAXSubstantially EquivalentCamber Spine Technologiesaccessdata.fda.gov
March 21, 2019K182074Mineral Collagen Composite Bioactive MoldableMQVSubstantially EquivalentCollagen Matrix, Inc.accessdata.fda.gov
October 27, 2018K180980ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization SystemNKBSubstantially EquivalentCamber Spine Technologies, LLCaccessdata.fda.gov
June 25, 2018K180724SPIRA Open Matrix LLIFMAXSubstantially EquivalentCamber Spine Technologies, LLCaccessdata.fda.gov
April 18, 2018K173432ENZA-A Titanium ALIFOVDSubstantially EquivalentCamber Spine Technologiesaccessdata.fda.gov
February 2, 2018K173800Camber Spine Technologies SPIRA - V™ Open Matrix Corpectomy CageMQPSubstantially EquivalentCamber Spine Technologiesaccessdata.fda.gov
November 7, 2017K172446SPIRA-C Open Matrix Cervical InterbodyODPSubstantially EquivalentCamber Spine Technologiesaccessdata.fda.gov
September 15, 2017K172064Ti-Diagon Oblique TLIFMAXSubstantially EquivalentCamber Spine Technologiesaccessdata.fda.gov
July 13, 2017K170550Coveris Cervical Cage SystemODPSubstantially EquivalentCamber Spine Technologiesaccessdata.fda.gov
June 12, 2017K162986SPIRA Open Matrix ALIFMAXSubstantially EquivalentCamber Spine Technologiesaccessdata.fda.gov
May 3, 2016K153720ENZA Zero-Profile Anterior Interbody FusionOVDSubstantially EquivalentCamber Spine Technologiesaccessdata.fda.gov
November 19, 2015K152259InFill Interbody Fusion DeviceMAXSubstantially EquivalentPinnacle Spine Group, LLCaccessdata.fda.gov
April 3, 2015K150206InFill Interbody Fusion DevicesMAXSubstantially EquivalentPinnacle Spine Group, LLCaccessdata.fda.gov
January 26, 2015K143490VERTA Corpectomy CageMQPSubstantially EquivalentCamber Spineaccessdata.fda.gov
December 17, 2014K143488InFill Graft Delivery SystemFMFSubstantially EquivalentPinnacle Spine Group, LLCaccessdata.fda.gov
December 2, 2014K141282PGS 5.5 MM CANNULATED PEDICLE SCREWNKBSubstantially EquivalentPinnacle Spine Groupaccessdata.fda.gov
April 8, 2014K133366ORTHROS POSTERIOR STABILIZATION SYSTEMNKBSubstantially EquivalentCamber Spineaccessdata.fda.gov
March 31, 2014K133721INFILL 41-TLIF CONVEX OBLIQUE DEVICE, INFILL 43-TLIF CONTOUR OBLIQUE, INFILL 44-TLIF CONTOUR OBLIQUE AND THE INFILL 60MAXSubstantially EquivalentPinnacle Spine Group, LLCaccessdata.fda.gov
March 20, 2014K134038CAMBER SPINE DIAGON OBLIQUE CAGEMAXSubstantially EquivalentCamber Spineaccessdata.fda.gov
March 20, 2014K133529CAMBER SPINE COVERIS CERVICAL CAGEODPSubstantially EquivalentCamber Spineaccessdata.fda.gov
January 11, 2013K121254CAMBER SPINE TECHNOLOGIES TLS 5.0 INERBODY CAGEMAXSubstantially EquivalentCamber Spine Technologiesaccessdata.fda.gov
August 29, 2012K121476INFILL GRAFT DELIVERY SYSTEMFMFSubstantially EquivalentPinnacle Spine Group, LLCaccessdata.fda.gov
July 13, 2012K121733INFILL INTERVERTEBRAL BODY FUSION DEVICEMAXSubstantially EquivalentPinnacle Spine Group, LLCaccessdata.fda.gov
April 18, 2011K103729INFILL INTERVERTEBRAL BODY FUSION DEVICEMAXSubstantially EquivalentPinnacle Spine Group, LLCaccessdata.fda.gov
January 25, 2006K052812OSSIMEND (TM) BONE GRAFT MATERIALMQVSubstantially EquivalentCollagen Matrix, Inc.accessdata.fda.gov

Compare with other makers

Updated July 12, 2024. 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.