G21 S R I

FDA Filings

This page includes the latest FDA filings for G21 S R I. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

G21 S R I holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

• STERIS SPA

FDA Registration(s)

• Registration Number: 3010898856
• FEI Number: 3010898856
• Name: G21 S.R.I.
• Owner & Operator: G21 s.r.l.
• Contact Address: Via S. Pertini, 8 ; San Possidonio IT-MO Modena 41039 IT
• Official Correspondent:
  • Maurizio Foroni
  • 39-0535-30312-x
• US Agent:
  • Barry E Sands
  • RQMIS Inc
  • 978 3587307
  • barrysands@rqmis.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: Via S. Pertini, 8 ; San Possidonio Modena, 41039 IT
• Establishment Type:
  • Complaint File Establishment per 21 CFR 820.198
  • Export Device to the United States But Perform No Other Operation on Device
  • Manufacture Medical Device

FDA Filings

Device Company	Device	Date
PMN K193061 | MBB G21 S.R.I. [G21 s.r.l.]	G3 40	2020-03-23
PMN K193061 | LOD G21 S.R.I. [G21 s.r.l.]	G3 40	2020-03-23
PMN K193059 | LOD G21 S.R.I. [G21 s.r.l.]	G1 40	2020-03-23
PMN K192041 | MBB G21 S.R.I. [G21 s.r.l.]	SpaceFlex Hip	2019-10-30
PMN K192041 | KWY G21 S.R.I. [G21 s.r.l.]	SpaceFlex Hip	2019-10-30
PMN K192041 | KWL G21 S.R.I. [G21 s.r.l.]	SpaceFlex Hip	2019-10-30
PMN K190216 | MBB G21 S.R.I. [G21 s.r.l.]	SpaceFlex Knee	2019-06-11
PMN K190216 | JWH G21 S.R.I. [G21 s.r.l.]	SpaceFlex Knee	2019-06-11
PMN K181282 | MBB G21 S.R.I. [G21 s.r.l.]	G3A 40 Bone Cement	2019-03-05
PMN K181282 | LOD G21 S.R.I. [G21 s.r.l.]	G3A 40 Bone Cement	2019-03-05
PMN K173494 | MBB G21 S.R.I. [G21 s.r.l.]	OrthoSteady G	2018-04-23
PMN K173494 | LOD G21 S.R.I. [G21 s.r.l.]	OrthoSteady G	2018-04-23
KIH G21 S.R.I. [G21 s.r.l.]	Flex Filler	2018-04-12
PMN K172214 | NDN G21 S.R.I. [G21 s.r.l.]	Winch Kyphoplasty 11 Gauge Balloon Catheters	2017-10-09
PMN K172214 | HRX G21 S.R.I. [G21 s.r.l.]	Winch Kyphoplasty 11 Gauge Balloon Catheters	2017-10-09
HTF G21 S.R.I. [G21 s.r.l.]	Curette - Flex Drill	2017-09-08
LXH G21 S.R.I. [G21 s.r.l.]	WKK TRADITIONAL ACCESS	2016-03-30
LXH G21 S.R.I. [G21 s.r.l.]	WKK Guide Wire, Trocar and Round Tip	2016-03-30
LXH G21 S.R.I. [G21 s.r.l.]	WKK First Acces Needle	2016-03-30
LXH G21 S.R.I. [G21 s.r.l.]	WKK Cannulated Working Cannula	2016-03-30
PMN K150408 | NDN G21 S.R.I. [G21 s.r.l.]	V-STEADY Bone Cement	2016-02-28
PMN K150408 | NDN G21 S.R.I. [G21 s.r.l.]	V-FAST Bone Cement	2016-02-28
PMN K150408 | LOD G21 S.R.I. [G21 s.r.l.]	V-STEADY Bone Cement	2016-02-28
PMN K150408 | LOD G21 S.R.I. [G21 s.r.l.]	V-FAST Bone Cement	2016-02-28
OAR G21 S.R.I. [G21 s.r.l.]	V-HP Gun, High pressure gun for bone cement injection	2016-02-28
OCJ G21 S.R.I. [G21 s.r.l.]	VacLok Vacuum Pressure Syringe	2016-02-21
OCJ G21 S.R.I. [G21 s.r.l.]	V-Access	2016-02-21
OCJ G21 S.R.I. [G21 s.r.l.]	KeyFix Direct Access Needle	2016-02-21
OCJ G21 S.R.I. [G21 s.r.l.]	KeyFix Bone Cement Filler Cannula	2016-02-21
OCJ G21 S.R.I. [G21 s.r.l.]	Blue Diamond Digital Inflation Device	2016-02-21
OCJ G21 S.R.I. [G21 s.r.l.]	Atrion QL2530 Inflation Device	2016-02-21
JDZ G21 S.R.I. [G21 s.r.l.]	PICOMIX V, MIXING SYSTEM AND DELIVERY SYRINGES	2016-02-21
JDZ G21 S.R.I. [G21 s.r.l.]	PICOMIX SYRINGE BONE CEMENT MIXING SYSTEM (180GR)	2016-02-21
JDZ G21 S.R.I. [G21 s.r.l.]	PICOMIX SYRINGE BONE CEMENT MIXING SYSTEM (120GR)	2016-02-21
JDZ G21 S.R.I. [G21 s.r.l.]	PICOMIX BOWL:BONE CEMENT CLOSED MIXING SYSTEM	2016-02-21
JDZ G21 S.R.I. [G21 s.r.l.]	DISP MIXING BOWL-O: OPEN MIXING SYSTEM FOR BONE CEMENT PREPARATION	2016-02-21
HTW G21 S.R.I. [G21 s.r.l.]	KeyFix Bone Drill	2016-02-21