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RTI Surgical, Inc. (dba RTI Biologics, Inc.)

USA · Alachua

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Canada — 3 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

33listed device types

Class I 20Class II 13Class III 0

plus 37 registration records and 28 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

1registered devices

Class I 1

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

2active device licences

Class IV 2

4 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States37 registration records, 28 510(k), 0 PMA, 2 excluded

Brazil1 confirmed, 0 excluded

Canada2 confirmed, 0 excluded

Manufacturer names merged into this page: RTI Surgical, Inc. (dba RTI Biologics, Inc.) · RTI SURGICAL, INC., ALSO DBA RTI BIOLOGICS, INC. · PIONEER SURGICAL TECHNOLOGY, INC. DBA RTI SURGICAL, INC.

Same-named companies — This database also contains companies with near-identical names: Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.), Rti Biologics, Inc., Rti Surgical, Inc., RTI SURGICAL, INC., ALSO DBA RTI BIOLOGICS, INC.. Company name alone cannot separate their registrations, so the figures below may include either.

FDA 510(k) clearances by year

12008

12009

12013

22014

32015

42016

52017

32019

52020

12023

22025

FDA listed device types

showing 8 of 33

Rasp 1Syringe, Restorative And Impression Material 1Clamp 1Guide, Surgical, Instrument 1Osteotome, Manual 1Screwdriver 1Reamer 1Bit, Surgical 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K253145	Pre-Sutured Tendon	2025-10-22
US	K241555	Moldable Bone Void Filler and Moldable Bone Void Filler + CCC	2025-02-21
US	K230036	Pre-Sutured Tendon (4561SC / Single Strand); Pre-Sutured Tendon (4564SC / Quadruple Strand )	2023-06-23
BR	80044680484	Instrumentais Cable-Ready	Class I
CA	67539	BONE VOID FILLER	Class IV
CA	80769	BONE VOID FILLERS	Class IV

RTI Surgical, Inc. (dba RTI Biologics, Inc.)

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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