FDA Device Entity Profile: ORTHOPEDIATRICS, CORP

Known Identifiers & Locations

FEI Numbers 3006460162

Owner Operator Numbers 9102640

Locations Covered Warsaw, IN, US

Registered Establishments (1)

Registration #	Establishment Name	Location	Establishment Type(s)	Action
3006460162	ORTHOPEDIATRICS, CORP	Warsaw, IN, US	Complaint File Establishment per 21 CFR 820.198,Repack or Relabel Medical Device,Develop Specifications But Do Not Manufacture At This Facility	View Details

510(k) Premarket Notifications (1)

Submission #	Device Name	Decision Date	Decision Description	Action
K082949	ORTHOPEDIATRICS BONE SCREWS	2008-11-25	Substantially Equivalent	View Details

FDA Recall History (0)

No recall records found for this entity.

Profile Disclaimer

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