FDA.reportPublic FDA data

Tyber Medical

Matched from indexed company URL: TYBER MEDICAL LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30129661833012966183Tyber Medical1N2026-01-0183 South Commerce Way Suite 310 Bethlehem PA US 18017
30179804953017980495Tyber Medical1N2026-01-0189 South Commerce Way Suite 990 Bethlehem PA US 18017

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
00196449035441Anatomic Access LLIF - Anatomic Access LLIF, Retractor Handle+1(888)761-0933regulatory@exalta.com
00196449035465Anatomic Access LLIF - Anatomic Access LLIF, Articulating Arm with Adaptor+1(888)761-0933regulatory@exalta.com
00196449035472Anatomic Access LLIF - Anatomic Access LLIF, Table/Bedrail Clamp+1(888)761-0933regulatory@exalta.com
00196449035489Anatomic Access LLIF - Anatomic Access LLIF, Core Retractor Set+1(888)761-0933regulatory@exalta.com
00196449035496Anatomic Access LLIF - Anatomic Access LLIF, Accessory Set+1(888)761-0933regulatory@exalta.com
00196449035502Anatomic Access LLIF - Anatomic Access LLIF, Outlier Retractor Set+1(888)761-0933regulatory@exalta.com
00196449035519Anatomic Access LLIF - Anatomic Access LLIF, Accessory Set Insert+1(888)761-0933regulatory@exalta.com
00196449035526Anatomic Access LLIF - Anatomic Access LLIF, Table Arm Set+1(888)761-0933regulatory@exalta.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2842881748771210K261060Navigated LLIF Impactable TrackerOLO2026-05-29
1994541748771210K261060Navigated LLIF Impactable TrackerOLO2026-05-29
1994541646213074K252742Navigated InstrumentsOLO2025-10-28
2842881646213074K252742Navigated InstrumentsOLO2025-10-28
2842881316587180K251361Tyber Medical Distal Radius Plating SystemHRS2025-07-30
1994541316587180K251361Tyber Medical Distal Radius Plating SystemHRS2025-07-30
2842881934581619K242486Tyber Medical Anatomical Plating SystemHRS2025-03-19
1994541934581619K242486Tyber Medical Anatomical Plating SystemHRS2025-03-19
2842881943572376K233423Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag SystemHRS2023-12-21
1994541943572376K233423Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag SystemHRS2023-12-21
2842881626768554K232693Tyber Medical Distal Radius Plating SystemHRS2023-12-04
1994541626768554K232693Tyber Medical Distal Radius Plating SystemHRS2023-12-04
1994541012290050K232652Anatomical Plating System (various)HRS2023-12-13
2842881012290050K232652Anatomical Plating System (various)HRS2023-12-13
1994541142846511K231339Tyber Medical Pin and Wire System (various)HTY2023-07-06
2842881142846511K231339Tyber Medical Pin and Wire System (various)HTY2023-07-06
1994541407401758K222465Tyber Medical Anatomical Plating SystemHRS2023-03-07
2842881407401758K222465Tyber Medical Anatomical Plating SystemHRS2023-03-07
2842881682267401K221947Tyber Medical Staple Fixation System (various)JDR2022-10-20
1994541682267401K221947Tyber Medical Staple Fixation System (various)JDR2022-10-20
1994541956496357K203817Tyber Medical Anatomical Plating SystemHRS2021-08-13
2842881956496357K203817Tyber Medical Anatomical Plating SystemHRS2021-08-13
2842881715604301K192975Tyber Medical Trauma ScrewsHWC2020-01-09
1994541715604301K192975Tyber Medical Trauma ScrewsHWC2020-01-09
1994541718694718K192974Tyber Medical Trauma ScrewHWC2020-01-08
2842881718694718K192974Tyber Medical Trauma ScrewHWC2020-01-08
1994541960262563K182284Tyber Medical PT Interbody SpacerODP2019-01-18
2842881471738725K172185Tyber Medical PT Interbody Spacer SystemODP2017-12-21
1994541471738725K172185Tyber Medical PT Interbody Spacer SystemODP2017-12-21
2842881490248856K171327Tyber Medical Wedge SystemPLF2017-05-16
1994541490248856K171327Tyber Medical Wedge SystemPLF2017-05-16
2842881696766684K170571Tyber Medical BioTy(TM) Nanotopography Trauma Screw, TyFix ScrewHWC2017-06-20
1994541696766684K170571Tyber Medical BioTy(TM) Nanotopography Trauma Screw, TyFix ScrewHWC2017-06-20
1994541745545863K161597Tyber Medical BioTy® Nanotopography Trauma ScrewHWC2016-11-16
2842881486869767K153575Tyber Medical Trauma ScrewHWC2016-02-26
1994541486869767K153575Tyber Medical Trauma ScrewHWC2016-02-26
1994541862441812K153180Tyber Medical MST Trauma ScrewHWC2015-11-25
1994541180632084K151241Synchro-Medical TIGER TRACK Screw SystemHWC2015-08-07
2842881299030890K150394Tyber Medical Wedge SystemPLF2015-07-28
1994541299030890K150394Tyber Medical Wedge SystemPLF2015-07-28
1994541192321876K133842TYBER MEDICAL TRAUMA SCREWHWC2014-03-20
2842881192321876K133842TYBER MEDICAL TRAUMA SCREWHWC2014-03-20
1994541098268432K133477TOEGRIP, IMPLANT FOR PROXIMAL INTER-PHALANGEAL ARTHRODESISHTY2014-02-10
1994541628666835K130573TYBER MEDICAL INTERBODY SYSTEM; ACIF, ALIF, PLIF, TLIF, DLIFODP2013-09-30
2842881628666835K130573TYBER MEDICAL INTERBODY SYSTEM; ACIF, ALIF, PLIF, TLIF, DLIFODP2013-09-30
1994541346942628K103068KING COBRA ANTERIOR CERVICAL PLATEKWQ2011-01-14
1994541061692002
2842881061692002
1994541150743437
2842881150743437
2842881213609607
1994541213609607
2842881288397823
1994541288397823
1994541316765587
2842881316765587
2842881393064689
1994541393064689
1994541466466930
2842881466466930
1994541466741445
2842881466741445
2842881473472380
1994541473472380
1994541568997592
2842881568997592
1994541639002869
2842881639002869
1994541752952663
2842881752952663
1994541783725614
2842881783725614
2842881868494062
1994541868494062
2842881933726004
1994541933726004
2842881948603006
1994541948603006

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
HWC152020-01-09
HRS142025-07-30
ODP72019-01-18
OLO42026-05-29
PLF42017-05-16
HTY32023-07-06
JDR22022-10-20
KWQ12011-01-14

PMN#

GUDID#

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