Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Tyber Medical, LLC · Predicate Candidate Screening

31 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

90 daysmedian FDA review time
204 days90th percentile
31clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC2026-06-12600
K260810Anteralign LS coverplateTyber Medical, LLC2026-06-10900
K261060Navigated LLIF Impactable TrackerTyber Medical, LLC2026-05-29590
K253042Tyber Medical Trauma ScrewTyber Medical, LLC2026-04-031930
K252901Tyber Medical Trauma ScrewTyber Medical, LLC2025-12-311110
K252742Navigated InstrumentsTyber Medical, LLC2025-10-28610
K251361Tyber Medical Distal Radius Plating SystemTyber Medical, LLC2025-07-30900
K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC2025-03-192100
K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC2024-05-31300
K233423Tyber Medical Anatomical Plating System – Line extension to Tyber Medical, LLC2023-12-21720
K233017TM Plating SystemTyber Medical, LLC2023-12-20890
K232652Anatomical Plating System (various)Tyber Medical, LLC2023-12-1310420
K232693Tyber Medical Distal Radius Plating SystemTyber Medical, LLC2023-12-04900
K231339Tyber Medical Pin and Wire System (various)Tyber Medical, LLC2023-07-06590
K222465Tyber Medical Anatomical Plating SystemTyber Medical, LLC2023-03-072040
K221947Tyber Medical Staple Fixation System (various)Tyber Medical, LLC2022-10-201070
K203817Tyber Medical Anatomical Plating SystemTyber Medical, LLC2021-08-132270
K193222Tyber Medical Anatomical Plating SystemTyber Medical, LLC2020-01-20590
K192975Tyber Medical Trauma ScrewsTyber Medical, LLC2020-01-09770
K192974Tyber Medical Trauma ScrewTyber Medical, LLC2020-01-08760
K182284Tyber Medical PT Interbody SpacerTyber Medical, LLC2019-01-181480
K180590Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC2018-07-061220
K172185Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC2017-12-211540
K170571Tyber Medical BioTy(TM) Nanotopography Trauma Screw, TyFix STyber Medical, LLC2017-06-201130
K171327Tyber Medical Wedge SystemTyber Medical, LLC2017-05-16110
K161597Tyber Medical BioTy® Nanotopography Trauma ScrewTyber Medical, LLC2016-11-161600
K153575Tyber Medical Trauma ScrewTyber Medical, LLC2016-02-26730
K153180Tyber Medical MST Trauma ScrewTyber Medical, LLC2015-11-25220
K150394Tyber Medical Wedge SystemTyber Medical, LLC2015-07-281600
K133842TYBER MEDICAL TRAUMA SCREWTyber Medical, LLC2014-03-20920
K130573TYBER MEDICAL INTERBODY SYSTEM; ACIF, ALIF, PLIF, TLIF, DLIFTyber Medical, LLC2013-09-302100

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda