FDA Device Entity Profile: Tyber Medical LLC

Known Identifiers & Locations

FEI Numbers 3012966183, 3017980495

Owner Operator Numbers 10046574

Locations Covered Bethlehem, PA, US

Registered Establishments (2)

Registration #	Establishment Name	Location	Establishment Type(s)	Action
3012966183	Tyber Medical	Bethlehem, PA, US	Repack or Relabel Medical Device	View Details
3017980495	Tyber Medical	Bethlehem, PA, US	Manufacture Medical Device,Repack or Relabel Medical Device,Complaint File Establishment per 21 CFR 820.198	View Details

510(k) Premarket Notifications (1)

Submission #	Device Name	Decision Date	Decision Description	Action
K192974	Tyber Medical Trauma Screw	2020-01-08	Substantially Equivalent	View Details

FDA Recall History (0)

No recall records found for this entity.

Profile Disclaimer

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