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Data / Medical devices / United States / Tyber Medical

Tyber Medical: FDA-registered device maker in Bethlehem, PA, United States, 24 510(k) clearances

Tyber Medical is registered with the FDA (registration 3012966183) in Bethlehem, PA, United States. It lists 26 device types. The FDA files 24 510(k) clearances under its listings, the newest dated June 12, 2026. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Tyber Medical
FDA registration number
3012966183
Address
83 South Commerce Way Suite 310, Bethlehem, PA, United States, 18017
Owner or operator
Tyber Medical LLC (10046574)
Roles
Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer
First device listed
April 9, 2014
Registered through
2026
Brand names listed
Anatomical Plating System, Anteralign LS Coverplate, BioTy Nanotopography Trauma Screw, Bit, drill, Box Cutter, Cobb, Countersink, Curette and more

Devices it lists

DeviceProduct codeClassRoleSource
Bit, DrillHTW1Complaint file establishment, Manufacturer, Repackager or relabeleraccessdata.fda.gov
Bone WedgePLF2Complaint file establishment, Manufacturer, Repackager or relabeleraccessdata.fda.gov
CountersinkHWW1Complaint file establishment, Manufacturer, Repackager or relabeleraccessdata.fda.gov
Curette, Surgical, General UseFZS1Complaint file establishment, Manufacturer, Repackager or relabeleraccessdata.fda.gov
Dissector, Surgical, General & Plastic SurgeryGDI1Complaint file establishment, Manufacturer, Repackager or relabeleraccessdata.fda.gov
Gauge, DepthHTJ1Complaint file establishment, Manufacturer, Repackager or relabeleraccessdata.fda.gov
Hammer, SurgicalFZY1Complaint file establishment, Manufacturer, Repackager or relabeleraccessdata.fda.gov
Instrument, Cutting, OrthopedicHTZ1Complaint file establishment, Manufacturer, Repackager or relabeleraccessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, CervicalODP2Complaint file establishment, Manufacturer, Repackager or relabeleraccessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, LumbarMAX2Complaint file establishment, Manufacturer, Repackager or relabeleraccessdata.fda.gov
Intervertebral Fusion Device With Integrated Fixation, LumbarOVD2Complaint file establishment, Manufacturer, Repackager or relabeleraccessdata.fda.gov
Orthopedic Manual Surgical InstrumentLXH1Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Orthopedic Stereotaxic InstrumentOLO2Complaint file establishment, Manufacturer, Repackager or relabeleraccessdata.fda.gov
OsteotomeHWM1Complaint file establishment, Manufacturer, Repackager or relabeleraccessdata.fda.gov
Pin, Fixation, SmoothHTY2Complaint file establishment, Manufacturer, Repackager or relabeleraccessdata.fda.gov
Plate, Fixation, BoneHRS2Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
RaspHTR1Complaint file establishment, Manufacturer, Repackager or relabeleraccessdata.fda.gov
ReamerHTO1Complaint file establishment, Manufacturer, Repackager or relabeleraccessdata.fda.gov
RetractorGAD1Complaint file establishment, Manufacturer, Repackager or relabeleraccessdata.fda.gov
RongeurHTX1Complaint file establishment, Manufacturer, Repackager or relabeleraccessdata.fda.gov
Screw, Fixation, BoneHWC2Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Screwdriver, SurgicalLRZ1Complaint file establishment, Manufacturer, Repackager or relabeleraccessdata.fda.gov
Staple, Fixation, BoneJDR2Complaint file establishment, Manufacturer, Repackager or relabeleraccessdata.fda.gov
TemplateHWT1Complaint file establishment, Manufacturer, Repackager or relabeleraccessdata.fda.gov
Tray, Surgical, InstrumentFSM1Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Washer, Bolt NutHTN2Complaint file establishment, Manufacturer, Repackager or relabeleraccessdata.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 12, 2026K261207Exalta Proximal Tibia Plating SystemHRSSubstantially EquivalentTyber Medical, LLCaccessdata.fda.gov
June 10, 2026K260810Anteralign LS coverplateOVDSubstantially EquivalentTyber Medical, LLCaccessdata.fda.gov
May 29, 2026K261060Navigated LLIF Impactable TrackerOLOSubstantially EquivalentTyber Medical, LLCaccessdata.fda.gov
October 28, 2025K252742Navigated InstrumentsOLOSubstantially EquivalentTyber Medical, LLCaccessdata.fda.gov
July 30, 2025K251361Tyber Medical Distal Radius Plating SystemHRSSubstantially EquivalentTyber Medical, LLCaccessdata.fda.gov
March 19, 2025K242486Tyber Medical Anatomical Plating SystemHRSSubstantially EquivalentTyber Medical, LLCaccessdata.fda.gov
December 21, 2023K233423Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag SystemHRSSubstantially EquivalentTyber Medical, LLCaccessdata.fda.gov
December 13, 2023K232652Anatomical Plating System (various)HRSSubstantially EquivalentTyber Medical, LLCaccessdata.fda.gov
December 4, 2023K232693Tyber Medical Distal Radius Plating SystemHRSSubstantially EquivalentTyber Medical, LLCaccessdata.fda.gov
July 6, 2023K231339Tyber Medical Pin and Wire System (various)HTYSubstantially EquivalentTyber Medical, LLCaccessdata.fda.gov
March 7, 2023K222465Tyber Medical Anatomical Plating SystemHRSSubstantially EquivalentTyber Medical, LLCaccessdata.fda.gov
October 20, 2022K221947Tyber Medical Staple Fixation System (various)JDRSubstantially EquivalentTyber Medical, LLCaccessdata.fda.gov
August 13, 2021K203817Tyber Medical Anatomical Plating SystemHRSSubstantially EquivalentTyber Medical, LLCaccessdata.fda.gov
January 9, 2020K192975Tyber Medical Trauma ScrewsHWCSubstantially EquivalentTyber Medical, LLCaccessdata.fda.gov
January 8, 2020K192974Tyber Medical Trauma ScrewHWCSubstantially EquivalentTyber Medical, LLCaccessdata.fda.gov
December 21, 2017K172185Tyber Medical PT Interbody Spacer SystemODPSubstantially EquivalentTyber Medical, LLCaccessdata.fda.gov
June 20, 2017K170571Tyber Medical BioTy(TM) Nanotopography Trauma Screw, TyFix ScrewHWCSubstantially EquivalentTyber Medical, LLCaccessdata.fda.gov
May 16, 2017K171327Tyber Medical Wedge SystemPLFSubstantially EquivalentTyber Medical, LLCaccessdata.fda.gov
February 26, 2016K153575Tyber Medical Trauma ScrewHWCSubstantially EquivalentTyber Medical, LLCaccessdata.fda.gov
August 7, 2015K151241Synchro-Medical TIGER TRACK Screw SystemHWCSubstantially EquivalentSynchro Medicalaccessdata.fda.gov
July 28, 2015K150394Tyber Medical Wedge SystemPLFSubstantially EquivalentTyber Medical, LLCaccessdata.fda.gov
March 20, 2014K133842TYBER MEDICAL TRAUMA SCREWHWCSubstantially EquivalentTyber Medical, LLCaccessdata.fda.gov
February 10, 2014K133477TOEGRIP, IMPLANT FOR PROXIMAL INTER-PHALANGEAL ARTHRODESISHTYSubstantially EquivalentSynchro Medicalaccessdata.fda.gov
September 30, 2013K130573TYBER MEDICAL INTERBODY SYSTEM; ACIF, ALIF, PLIF, TLIF, DLIFODPSubstantially EquivalentTyber Medical, LLCaccessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

InitiatedEventClassStatusProductReasonSource
December 19, 202598214Class IIOngoingBrand Name: VOLT" Wrist Treatment System Product Name: 2.4/2.7 2Column Dist Radius Plate 6Hd/10Shaft/Left/Std/139mm Model/Catalog Number: 02.426.681S Product Description: 2 Column Distal Radius Plate - 6 Head, 10 Shaft, The supplier manufactured anatomical left plates with an incorrect thread orientation.accessdata.fda.gov
January 21, 202596212Class IIOngoingA.L.P.S. mvX - ANATOMIC LAT FIB PLATE 4H LT: Anatomic Lateral Fibula Plate, 4-hole, Left Intended for Fixation of fractures of the distal tibia Model/Catalog Number: 770708041Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devicesaccessdata.fda.gov

Compare with other makers

Updated June 12, 2026. 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.