Norman Noble Inc

FDA Filings

This page includes the latest FDA filings for Norman Noble Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 1531050
• FEI Number: 3002755653
• Name: NORMAN NOBLE, INC.
• Owner & Operator: Norman Noble, Inc.
• Contact Address: 5507 Avion Park Drive ; Highland Heights OH 44143 US
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 5507 Avion Park Drive ; Highland Heights, OH 44143 US
• Establishment Type: Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device Company	Device	Date
PMN K170547 | HRS NORMAN NOBLE, INC.	Mesh Plate	2019-03-11
PMN K180377 | HWC NORMAN NOBLE, INC.	CoLink	2019-02-13
PMN K170518 | HWC NORMAN NOBLE, INC.	CoLag	2019-02-13
PMN K170594 | HWC NORMAN NOBLE, INC.	Colink Plating System	2017-11-06
PMN K170382 | HWC NORMAN NOBLE, INC.	QuickFix Cannulated Screw System	2017-11-06
PMN K161778 | HWC NORMAN NOBLE, INC.	ToeTac Hammertoe Fixation System	2017-11-06
PMN K020247 | MNI NORMAN NOBLE, INC.	COLORADO 2 SPINAL SYSTEM	2017-02-13
PMN K020247 | MNH NORMAN NOBLE, INC.	COLORADO 2 SPINAL SYSTEM	2017-02-13
PMN K020247 | KWQ NORMAN NOBLE, INC.	COLORADO 2 SPINAL SYSTEM	2017-02-13
PMN K020247 | KWP NORMAN NOBLE, INC.	COLORADO 2 SPINAL SYSTEM	2017-02-13
PMN K151732 | HRS NORMAN NOBLE, INC.	Arthrex Fracture Plates	2016-09-20
PMN K141735 | HRS NORMAN NOBLE, INC.	Arthrex Ankle Fusion Plating System	2016-09-20
PMN K032187 | HRS NORMAN NOBLE, INC.	Arthrex Titanium Opening Wedge Osteotomy System	2016-09-20
PMN K153333 | HWC NORMAN NOBLE, INC.	Epic Extremity Cannulated Screw System	2016-04-25
PMN K152974 | HRS NORMAN NOBLE, INC.	Ortholoc 3Di Foot Plating Reconstruction System	2016-04-25
PMN K150896 | OSH NORMAN NOBLE, INC.	Vitality Spinal Fixation System	2016-04-25
PMN K150896 | NKB NORMAN NOBLE, INC.	Vitality Spinal Fixation System	2016-04-25
PMN K150896 | MNI NORMAN NOBLE, INC.	Vitality Spinal Fixation System	2016-04-25
PMN K150896 | MNH NORMAN NOBLE, INC.	Vitality Spinal Fixation System	2016-04-25
PMN K150896 | KWQ NORMAN NOBLE, INC.	Vitality Spinal Fixation System	2016-04-25
PMN K150896 | KWP NORMAN NOBLE, INC.	Vitality Spinal Fixation System	2016-04-25
PMN K130050 | KWS NORMAN NOBLE, INC.	Titan Reverse Shoulder System	2016-03-07
PMN K143402 | HWC NORMAN NOBLE, INC.	IO Fix Trio	2015-12-04
PMN K143402 | HRS NORMAN NOBLE, INC.	IO Fix Trio	2015-12-04
PMN K133636 | HWC NORMAN NOBLE, INC.	HammerFiX	2014-04-17
PMN K120493 | HWC NORMAN NOBLE, INC.	Mini	2013-10-28
PMN K131620 | HWC NORMAN NOBLE, INC.	Jones Screw	2013-09-03
PMN K123241 | HWC NORMAN NOBLE, INC.	Screw, Fixation, Bone	2013-06-03
PMN K123241 | HWC NORMAN NOBLE, INC.	Plate, Fixation, Bone	2013-06-03
PMN K123241 | HRS NORMAN NOBLE, INC.	Screw, Fixation, Bone	2013-06-03
PMN K123241 | HRS NORMAN NOBLE, INC.	Plate, Fixation, Bone	2013-06-03
PMN K103705 | HWC NORMAN NOBLE, INC.	Low Profile Screw	2013-04-15
PMN K103705 | HRS NORMAN NOBLE, INC.	Low Profile Screw	2013-04-15
PMN K101700 | HWC NORMAN NOBLE, INC.	IO Fix	2013-04-15
PMN K052614 | HWC NORMAN NOBLE, INC.	Low Profile Screw & Plate	2013-04-15
PMN K052614 | HRS NORMAN NOBLE, INC.	Low Profile Screw & Plate	2013-04-15
PMN K121417 | HWC NORMAN NOBLE, INC.	XMCP	2013-02-11
PMN K112237 | MBI NORMAN NOBLE, INC.	Microsuture Anchors	2013-01-21
PMN K112237 | MAI NORMAN NOBLE, INC.	Microsuture Anchors	2013-01-21
PMN K112237 | HWC NORMAN NOBLE, INC.	Microsuture Anchors	2013-01-21
HWT NORMAN NOBLE, INC.	Biomet Microfixation Bone Plate Templates; Lactosorb Plate Templates; Pectus Bar Template; TMJ Mandibular or Fossa Trial	2013-01-21
PMN P890017 | MAF NORMAN NOBLE, INC.	PALMAZ Balloon-Expandable Stent	2012-10-30
PMN K993091 | FGE NORMAN NOBLE, INC.	PALMAZ XL Transhepatic Biliary Stent	2012-10-30
PMN K920289 | DWZ NORMAN NOBLE, INC.	BIPAL Biopsy Forceps	2012-10-30
PMN K911581 | FGE NORMAN NOBLE, INC.	PALMAZ Transhepatic Biliary Stent	2012-10-30
PMN K905720 | DQY NORMAN NOBLE, INC.	PALMAZ Transhepatic Biliary Stent	2012-10-30
PMN K020809 | FGE NORMAN NOBLE, INC.	PALMAZ GENESIS Transhepatic Biliary Stent	2012-10-30
PMN K012090 | FGE NORMAN NOBLE, INC.	PALMAZ GENESIS Transhepatic Biliary Stent	2012-10-30
PMN K012087 | FGE NORMAN NOBLE, INC.	PALMAZ GENESIS Transhepatic Biliary Stent	2012-10-30

Related Finance Registrations

NCAGE Code	13889	NORMAN NOBLE, INC.!DBA N N I
CAGE Code	13889	NORMAN NOBLE, INC. N N I
S.A.M. Registration	13889 [72804292]	NORMAN NOBLE, INC. N N I

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
202005256357	Pusan,South Korea -> New York/Newark Area, Newark, New Jersey	TUNGSTEN LEAF BLANK	8 PKG
202005112892	Pusan,South Korea -> New York/Newark Area, Newark, New Jersey	TUNGSTEN LEAF BLANK SHIELDING ARC BLOCK	9 PKG
202004089060	Pusan,South Korea -> New York/Newark Area, Newark, New Jersey	TUNGSTEN LEAF BLANK	2 PKG
202003124682	Pusan,South Korea -> New York/Newark Area, Newark, New Jersey	TUNGSTEN LEAF BLANK	8 PKG
202003114466	Pusan,South Korea -> New York/Newark Area, Newark, New Jersey	TUNGSTEN LEAF BLANK	8 PKG