Spectrum Plastics Group

FDA Filings

This page includes the latest FDA filings for Spectrum Plastics Group. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Spectrum Plastics Group holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

• Medical Molding & Manufacturing de Mexico S. de R.L. de C.V.

FDA Registration(s)

• Registration Number: 2183967
• FEI Number: 1000115735
• Name: Spectrum Plastics Group
• Owner & Operator: Spectrum Plastics Group
• Contact Address: 7309 West 27th --; Minneapolis MN 55426 US
• Official Correspondent:
  • Dan Amundson
  • x-763-9272453-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 7309 WEST 27TH ST. ; Saint Louis Park, MN 55426 US
• Establishment Type: Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device Company	Device	Date
PMN K120163 | HRS Spectrum Plastics Group	BioBridge Resorbable Chest Wall Stabilization Plate	2019-07-10
PMN K180149 | LFL Spectrum Plastics Group	SCBIGA	2018-08-16
PMN K151220 | MBI Spectrum Plastics Group	Interference Screw	2016-11-04
PMN K161191 | NHB Spectrum Plastics Group	Latera Absorbable Nasal Implant	2016-06-30
PMN K132920 | NHB Spectrum Plastics Group	Self Anchoring Rod, Injectable	2015-10-16
PMN K141577 | HTY Spectrum Plastics Group	Pin, Fixation, Smooth	2014-10-22
PMN K101823 | MAI Spectrum Plastics Group	Screw, Fixation, Bone	2013-02-19
PMN K101823 | MAI Spectrum Plastics Group	Fastener, Fixation, Biodegradable, Soft	2013-02-19
PMN K101823 | HWC Spectrum Plastics Group	Screw, Fixation, Bone	2013-02-19
PMN K101823 | HWC Spectrum Plastics Group	Fastener, Fixation, Biodegradable, Soft	2013-02-19
PMN K101679 | MAI Spectrum Plastics Group	Screw, Fixation, Bone	2013-02-19
PMN K101679 | MAI Spectrum Plastics Group	Fastener, Fixation, Biodegradable, Soft	2013-02-19
PMN K101679 | HWC Spectrum Plastics Group	Screw, Fixation, Bone	2013-02-19
PMN K101679 | HWC Spectrum Plastics Group	Fastener, Fixation, Biodegradable, Soft	2013-02-19
PMN K082810 | MAI Spectrum Plastics Group	Screw, Fixation, Bone	2013-02-19
PMN K082810 | MAI Spectrum Plastics Group	Fastener, Fixation, Biodegradable, Soft	2013-02-19
PMN K082810 | HWC Spectrum Plastics Group	Screw, Fixation, Bone	2013-02-19
PMN K082810 | HWC Spectrum Plastics Group	Fastener, Fixation, Biodegradable, Soft	2013-02-19
PMN K061863 | MBI Spectrum Plastics Group	Screw, Fixation, Bone	2013-02-19
PMN K061863 | MAI Spectrum Plastics Group	Screw, Fixation, Bone	2013-02-19
PMN K061863 | JDR Spectrum Plastics Group	Screw, Fixation, Bone	2013-02-19
PMN K061863 | HWC Spectrum Plastics Group	Screw, Fixation, Bone	2013-02-19
PMN K043337 | HWC Spectrum Plastics Group	Screw, Fixation, Bone	2013-02-19
PMN K093310 | MVR Spectrum Plastics Group	GEM FlowCOUPLER	2013-02-18
PMN K093310 | DPW Spectrum Plastics Group	GEM FlowCOUPLER	2013-02-18
PMN K071616 | HTY Spectrum Plastics Group	Biotrak Resorbable Pin	2013-02-18
PMN K061763 | HWC Spectrum Plastics Group	Biotrak Headless Resorbable Compression Screw	2013-02-18
PMN K061763 | HWC Spectrum Plastics Group	Arc Surgical BioTrak Screw	2013-02-18
PMN K043176 | HWC Spectrum Plastics Group	Biotrak Screw System	2013-02-18
PMN K043176 | HWC Spectrum Plastics Group	ARC SURGICAL RESORBABLE	2013-02-18
PMN K040163 | MVR Spectrum Plastics Group	GEM COUPLER	2013-02-18