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RSB SPINE LLC.

USA · Wooster

✓ Record-verifiedregistrations found in 1 markets

This company has registrations in United States — 1 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

52listed device types

Class I 46Class II 6Class III 0

plus 52 registration records and 7 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

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

0active device licences

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 States52 registration records, 7 510(k), 0 PMA

Manufacturer names merged into this page: RSB SPINE LLC.

FDA 510(k) clearances by year

12006 · K061401

32007 · K071922

12008 · K081194

12009 · K092070

12010 · K092540

FDA listed device types

showing 8 of 52

Forceps 1Rasp 1Chisel (Osteotome) 1Hook, Bone 1Chisel, Surgical, Manual 1Elevator 1Instrument, Ligature Passing And Knot Tying 1Gouge, Surgical, General & Plastic Surgery 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K092540	C-PS PEEK OPTIMA CERVICAL INTERBODY SPACER, L-PS PEEK OPTIMA LUMBAR INTERBODY SPACER	2010-01-27
US	K092070	INTERPLATE C	2009-10-06
US	K081194	INTERPLATE PEEK CERVICAL INTERBODY FUSION DEVICE (IFD)	2008-05-29

RSB SPINE LLC.

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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