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Pioneer Surgical Technology, Inc.

USA · Marquette

✓ 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

44listed device types

Class I 30Class II 14Class III 0

plus 67 registration records and 98 510(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 III 2

12 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 States67 registration records, 98 510(k), 0 PMA, 13 excluded

Brazil1 confirmed, 1 excluded

Saudi Arabia0 confirmed, 1 excluded

Canada2 confirmed, 3 excluded

Manufacturer names merged into this page: Pioneer Surgical Technology, Inc. · PIONEER SURGICAL TECHNOLOGY INC. · PIONEER SURGICAL TECHNOLOGY, INC. DBA RTI SURGICAL, INC.

FDA 510(k) clearances by year

32005

12006

32007

72008

42009

72010

82011

62012

42013

72014

32015

42016

22017

42019

52020

12021

22022

12023

12025

12026

FDA listed device types

showing 8 of 44

Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component 1Posterior Cervical Screw System 1Thoracolumbosacral Pedicle Screw System 1Appliance, Fixation, Spinal Intervertebral Body 1Intervertebral Fusion Device With Bone Graft, Lumbar 1Plate, Fixation, Bone 1Cerclage, Fixation 1Intervertebral Fusion Device With Bone Graft, Cervical 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K261271	Cable-Ready® Cable Grip System	2026-07-16
US	K251436	Resolve Anterior Cervical Plate System	2025-07-11
US	K230993	CODA Anterior Cervical Plate System	2023-06-20
BR	80044680484	Instrumentais Cable-Ready	Class I
CA	37130	STAYFUSE	Class III
CA	88333	RELEASE LAMINOPLASTY SYSTEM	Class III

Pioneer Surgical Technology, 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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