Osteomed

FDA Filings

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

FDA Registration(s)

• Registration Number: 2027754
• FEI Number: 2027754
• Name: OSTEOMED
• Owner & Operator: OSTEOMED
• Contact Address: 3885 Arapaho Rd. --; Addison TX 75001 US
• Official Correspondent:
  • Kathryn Jayne
  • x-972-6774600-4766
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 3885 Arapaho Rd ; ADDISON, TX 75001 US
• Establishment Type:
  • Manufacture Medical Device
  • Develop Specifications But Do Not Manufacture At This Facility
  • Complaint File Establishment per 21 CFR 820.198
  • Manufacture Device in the United States for Export Only
  • Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device Company	Device	Date
PMN K203479 OsteoMed	ExtremiLOCK Lateral Ankle Fusion Plates	2021-02-24
PMN K100986 | MQV OSTEOMED	OM OsteoVation EX Impact	2019-03-13
PMN K051784 | GXP OSTEOMED	OM OsteoVation RMx Inject	2019-03-13
PMN K051784 | GXP OSTEOMED	OM OsteoVation Inject	2019-03-13
PMN K051784 | GXP OSTEOMED	OM OsteoVation Impact	2019-03-13
PMN K051784 | FWP OSTEOMED	OM OsteoVation RMx Inject	2019-03-13
PMN K051784 | FWP OSTEOMED	OM OsteoVation Inject	2019-03-13
PMN K051784 | FWP OSTEOMED	OM OsteoVation Impact	2019-03-13
PMN K051123 | MQV OSTEOMED	OM OsteoVation EX Inject	2019-03-13
PMN K162542 OSTEOMED	OsteoMed PINNACLE Driver	2017-05-19
PMN K162544 OSTEOMED	OsteoMed PINNACLE Driver	2017-04-04
PMN K161041 OSTEOMED	OsteoMed ExtremiLOCK Wrist Plating System	2016-05-19
PMN K152145 OSTEOMED	OsteoMed ExtremiLOCK Wrist Plating System	2015-12-21
PMN K151195 OSTEOMED	OsteoMed IMF Screw	2015-09-21
EJL OSTEOMED	Dental Burs	2015-09-14
KQW OSTEOMED	Goniometer	2014-12-30
KIK OSTEOMED	Sharp Hook	2014-12-30
HWN OSTEOMED	Compressor Instrument	2014-12-30
HTF OSTEOMED	Ring Curette	2014-12-30
HTF OSTEOMED	Cup Curette	2014-12-30
GEA OSTEOMED	PRIMALOK? FF	2014-12-29
GEA OSTEOMED	M3M4	2014-12-29
GEA OSTEOMED	2.0 Orthognathic	2014-12-29
PMN K140978 OSTEOMED	OSTEOMED LOW PROFILE ORBITAL FLOOR PLATE SYSTEM	2014-12-18
PMN K140283 OSTEOMED	OSTEOMED EXTREMIFUSE SYSTEM	2014-02-28
PMN K131851 OSTEOMED	OSTEOMED NEURO RONGEUR	2013-12-06
PMN K133437 OSTEOMED	1ST MTP PLATE	2013-12-02
PMN K130412 OSTEOMED	OSTEOMED EXTREMIFUSE SYSTEM	2013-05-31
PMN K121304 OSTEOMED	OSTEOMED CRANIAL DISTRACTION SYSTEM	2012-08-22
MDM OSTEOMED	KOBYGARD SYSTEM	2004-05-07
HWE OSTEOMED	OSTEOHARVESTER BONE HARVESTER	2001-09-28
HWE OSTEOMED	BONE COLLECTOR	2001-09-28

Similar & Related FDA Registered Companies

• OsteoMed LLC
• Osteomed Implantes, LTDA
• OSTEOMED CORP.
• OSTEOMED L.P.
• OSTEOMEDICS, INC.
• OSTEOMEDICS
• OSTEOMEDIX, INC.