Structure Medical L L C

FDA Filings

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

FDA Registration(s)

• Registration Number: 3009883317
• FEI Number: 3009883317
• Name: Structure Medical, LLC
• Owner & Operator: Structure Medical, LLC
• Contact Address: 505 Production Ave ; Madison AL 35758 US
• Official Correspondent:
  • Dean McCann
  • 1-239-2625551-203
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 505 Production Ave ; Madison, AL 35758 US
• Establishment Type: Manufacture Medical Device for Another Party (Contract Manufacturer)

• Registration Number: 3009322142
• FEI Number: 3009322142
• Name: Structure Medical, LLC
• Owner & Operator: Structure Medical, LLC
• Contact Address: 505 Production Ave ; Madison AL 35758 US
• Official Correspondent:
  • Dean McCann
  • 1-239-2625551-203
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 3511 Plover Ave ; Naples, FL 34117 US
• Establishment Type: Manufacture Medical Device for Another Party (Contract Manufacturer)

• Registration Number: 3006783837
• FEI Number: 3006783837
• Name: STRUCTURE MEDICAL, LLC.
• Owner & Operator: Structure Medical, LLC.
• Contact Address: 9935 Business Circle ; Naples FL 34112 US
• Official Correspondent:
  • Dean McCann
  • 1-239-2625551-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 9935 Business Circle ; Naples, FL 34112 US
• Establishment Type: Manufacture Medical Device for Another Party (Contract Manufacturer)

• Registration Number: 3007993775
• FEI Number: 3007993775
• Name: Structure Medical, LLC.
• Owner & Operator: Structure Medical, LLC.
• Contact Address: 9935 Business Circle ; Naples FL 34112 US
• Official Correspondent:
  • Dean McCann
  • 1-239-2625551-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 111 Cayuga Dr. ; Mooresville, NC 28117 US
• Establishment Type: Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device Company	Device	Date
PMN K200151 | HSX Structure Medical, LLC	Persona Partial Knee System	2020-03-25
PMN K200151 | HSX Structure Medical, LLC	Persona Partial Knee System	2020-03-25
PMN K200151 | HSX Structure Medical, LLC.	Persona Partial Knee System	2020-03-25
PMN K200151 | HSX STRUCTURE MEDICAL, LLC.	Persona Partial Knee System	2020-03-25
PMN K131670 | HRS Structure Medical, LLC.	A.L.P.S.1ST MTP FUSION PLATE LARGE	2020-03-25
PMN K131670 | HRS STRUCTURE MEDICAL, LLC.	A.L.P.S.1ST MTP FUSION PLATE LARGE	2020-03-25
PMN K111663 | HRS Structure Medical, LLC.	PROXIMAL RADIUS PLATE	2020-03-25
PMN K111663 | HRS Structure Medical, LLC.	OLECRANON PLATE	2020-03-25
PMN K111663 | HRS Structure Medical, LLC.	LOW PROFILE CORTICAL WASHER	2020-03-25
PMN K111663 | HRS Structure Medical, LLC.	F? FRAGMENT PLATING SYSTEMSMALL FRAG LOCKING PLATE	2020-03-25
PMN K111663 | HRS Structure Medical, LLC.	DISTAL HUMERAL MEDIAL PLATE	2020-03-25
PMN K111663 | HRS Structure Medical, LLC.	DISTAL HUMERAL LATERAL PLATE	2020-03-25
PMN K111663 | HRS Structure Medical, LLC.	CORONOID PLATE	2020-03-25
PMN K111663 | HRS Structure Medical, LLC.	A.L.P.S. ELBOW SYSTEMDISTAL HUMERAL POSTERIOR LATERAL PLATE	2020-03-25
PMN K111663 | HRS Structure Medical, LLC.	A.L.P.S. ELBOW SYSTEMDISTAL HUMERAL LATERAL PLATE	2020-03-25
PMN K111663 | HRS Structure Medical, LLC.	A.L.P.S. ELBOW SYSTEM OLECRANON PLATE	2020-03-25
PMN K111663 | HRS Structure Medical, LLC.	A.L.P.S. ELBOW SYSTEM DISTAL HUMERAL MEDIAL PLATE	2020-03-25
PMN K111663 | HRS STRUCTURE MEDICAL, LLC.	PROXIMAL RADIUS PLATE	2020-03-25
PMN K111663 | HRS STRUCTURE MEDICAL, LLC.	OLECRANON PLATE	2020-03-25
PMN K111663 | HRS STRUCTURE MEDICAL, LLC.	LOW PROFILE CORTICAL WASHER	2020-03-25
PMN K111663 | HRS STRUCTURE MEDICAL, LLC.	F? FRAGMENT PLATING SYSTEMSMALL FRAG LOCKING PLATE	2020-03-25
PMN K111663 | HRS STRUCTURE MEDICAL, LLC.	DISTAL HUMERAL MEDIAL PLATE	2020-03-25
PMN K111663 | HRS STRUCTURE MEDICAL, LLC.	DISTAL HUMERAL LATERAL PLATE	2020-03-25
PMN K111663 | HRS STRUCTURE MEDICAL, LLC.	CORONOID PLATE	2020-03-25
PMN K111663 | HRS STRUCTURE MEDICAL, LLC.	A.L.P.S. ELBOW SYSTEMDISTAL HUMERAL POSTERIOR LATERAL PLATE	2020-03-25
PMN K111663 | HRS STRUCTURE MEDICAL, LLC.	A.L.P.S. ELBOW SYSTEMDISTAL HUMERAL LATERAL PLATE	2020-03-25
PMN K111663 | HRS STRUCTURE MEDICAL, LLC.	A.L.P.S. ELBOW SYSTEM OLECRANON PLATE	2020-03-25
PMN K111663 | HRS STRUCTURE MEDICAL, LLC.	A.L.P.S. ELBOW SYSTEM DISTAL HUMERAL MEDIAL PLATE	2020-03-25
PMN K173767 | HRS STRUCTURE MEDICAL, LLC.	A.L.P.S. Clavicle Plating System	2020-02-14
FTY Structure Medical, LLC	4.5 Direct Measuring Device	2019-08-31
FTY Structure Medical, LLC	3.5 Direct Measuring Device	2019-08-31
PMN K171590 | HWC Structure Medical, LLC.	Distal Elbow Plating System	2019-08-09
PMN K171590 | HWC STRUCTURE MEDICAL, LLC.	Distal Elbow Plating System	2019-08-09
PMN K171590 | HRS Structure Medical, LLC.	Distal Elbow Plating System	2019-08-09
PMN K171590 | HRS STRUCTURE MEDICAL, LLC.	Distal Elbow Plating System	2019-08-09
PMN K153208 | OZI Structure Medical, LLC.	Internal Joint Stabilizer - Elbow	2019-08-09
PMN K153208 | OZI STRUCTURE MEDICAL, LLC.	Internal Joint Stabilizer - Elbow	2019-08-09
PMN K153208 | LXT Structure Medical, LLC.	Internal Joint Stabilizer - Elbow	2019-08-09
PMN K153208 | LXT STRUCTURE MEDICAL, LLC.	Internal Joint Stabilizer - Elbow	2019-08-09
LXH STRUCTURE MEDICAL, LLC.	Reduction Spin Knob	2018-12-29
PMN K181390 | KWP STRUCTURE MEDICAL, LLC.	Set Screw, Large	2018-12-04
PMN K081934 | HWC STRUCTURE MEDICAL, LLC.	K121349	2017-08-04
PMN K140431 | KTT Structure Medical, LLC	PediLoc Fragment System	2015-01-16
PMN K140431 | HWC Structure Medical, LLC	PediLoc Fragment System	2015-01-16
PMN K140431 | HTN Structure Medical, LLC	PediLoc Fragment System	2015-01-16
PMN K140431 | HRS Structure Medical, LLC	PediLoc Fragment System	2015-01-16
PMN K140411 | MAX Structure Medical, LLC	Altera	2015-01-16
PMN K124058 | OSH Structure Medical, LLC	Creo	2015-01-16
PMN K124058 | NKB Structure Medical, LLC	Creo	2015-01-16
PMN K124058 | MNI Structure Medical, LLC	Creo	2015-01-16
PMN K124058 | MNH Structure Medical, LLC	Creo	2015-01-16
PMN K124058 | KWQ Structure Medical, LLC	Creo	2015-01-16
PMN K124058 | KWP Structure Medical, LLC	Creo	2015-01-16
PMN K123231 | MAX Structure Medical, LLC	Caliber	2015-01-16
PMN K090666 | OBT Structure Medical, LLC	Pedi Plates	2013-10-31
PMN K090666 | HWC Structure Medical, LLC	Pedi Plates	2013-10-31
PMN K090666 | HRS Structure Medical, LLC	Pedi Plates	2013-10-31
PMN K073344 | HWC Structure Medical, LLC	Pedi Plates	2013-10-29
PMN K073344 | HRS Structure Medical, LLC	Pedi Plates	2013-10-29
PMN K061863 | MBI Structure Medical, LLC	Screw, Fixation, Bone	2013-01-09
PMN K061863 | MAI Structure Medical, LLC	Screw, Fixation, Bone	2013-01-09
PMN K061863 | JDR Structure Medical, LLC	Screw, Fixation, Bone	2013-01-09
PMN K061863 | HWC Structure Medical, LLC	Screw, Fixation, Bone	2013-01-09
PMN K052776 | HTN Structure Medical, LLC	Washer, Bolt Nut	2013-01-09
PMN K101525 | KWP Structure Medical, LLC	Plate	2012-12-26
PMN K090222 | KWQ Structure Medical, LLC	Anterior Plate	2012-12-26
PMN K000734 | KTT Structure Medical, LLC	Screw, Cap, Hex, Cerclage or Sleeve	2012-12-26
PMN K110700 | HWC Structure Medical, LLC	Humeral Fracture Plate System	2012-12-07
PMN K110700 | HRS Structure Medical, LLC	Humeral Fracture Plate System	2012-12-07
PMN K094037 | HRS Structure Medical, LLC	TC Plating System	2012-12-07
PMN K093055 | HWC Structure Medical, LLC	CSTS Screw	2012-12-07
PMN K071243 | KWD Structure Medical, LLC	Metal Hemi Implant	2012-12-07
PMN K051017 | KTT Structure Medical, LLC	R-X-Fix External Fixator	2012-12-07
PMN K042310 | HWC Structure Medical, LLC	Orthopro Bone Screw	2012-12-07
PMN K032682 | HWC Structure Medical, LLC	Orthopro STS Screw	2012-12-07
PMN K120906 | HSN Structure Medical, LLC	Zimmer Trabecular Metal Total Ankle	2012-12-04
PMN K120291 | OSH Structure Medical, LLC	Response Spinal System	2012-11-29
PMN K120291 | KWP Structure Medical, LLC	Response Spinal System	2012-11-29
PMN K111746 | MBF Structure Medical, LLC	Compr Srs Seas Hmrl Head 44x17, 48 x 19, 54 x 22, 40 x 15	2012-11-29
PMN K111746 | KWT Structure Medical, LLC	Compr Srs Seas Hmrl Head 44x17, 48 x 19, 54 x 22, 40 x 15	2012-11-29
PMN K111746 | KWS Structure Medical, LLC	Compr Srs Seas Hmrl Head 44x17, 48 x 19, 54 x 22, 40 x 15	2012-11-29
PMN K111746 | JDC Structure Medical, LLC	Compr Srs Seas Hmrl Head 44x17, 48 x 19, 54 x 22, 40 x 15	2012-11-29
PMN K111086 | HWC Structure Medical, LLC	Locking Proximal Femur Plate	2012-11-29
PMN K111086 | HRS Structure Medical, LLC	Locking Proximal Femur Plate	2012-11-29
PMN K110959 | HWC Structure Medical, LLC	Locking Cannulated Blade Plate	2012-11-29
PMN K110959 | HRS Structure Medical, LLC	Locking Cannulated Blade Plate	2012-11-29
PMN K100240 | HWC Structure Medical, LLC	Pediloc Tibia	2012-11-29
PMN K100240 | HRS Structure Medical, LLC	Pediloc Tibia	2012-11-29
PMN K083726 | HSB Structure Medical, LLC	PediNail	2012-11-29
PMN K083286 | HWC Structure Medical, LLC	Pediloc	2012-11-29
PMN K083286 | HRS Structure Medical, LLC	Pediloc	2012-11-29
PMN K082949 | HWC Structure Medical, LLC	Bone Screws	2012-11-29
PMN K082375 | HTY Structure Medical, LLC	PediFlex (Line Extension & SS)	2012-11-29
PMN K081407 | OBT Structure Medical, LLC	PediPlates	2012-11-29
PMN K081407 | HWC Structure Medical, LLC	PediPlates	2012-11-29
PMN K081407 | HRS Structure Medical, LLC	PediPlates	2012-11-29
PMN K081097 | HTY Structure Medical, LLC	PediFlex (Ti version only)	2012-11-29
EIG Structure Medical, LLC	Snap On Cheek Retractor	2012-11-28
PMN K940230 | HRX Structure Medical, LLC	EDIN	2012-11-08
PMN K925083 | HRX Structure Medical, LLC	EPF	2012-11-08
PMN K922391 | HRX Structure Medical, LLC	ECTR	2012-11-08
PMN K111264 | ODP Structure Medical, LLC	CORNERSTONE (R) PSR CERVICAL FUSION SYSTEM	2012-11-08
PMN K111032 | HTN Structure Medical, LLC	CMC Cable FIX	2012-11-08
PMN K094042 | OVE Structure Medical, LLC	PEEK PREVAIL CERVICAL INTERBODY DEVICE	2012-11-08
PMN K091813 | OVD Structure Medical, LLC	INTREPID SPINAL SYSTEM	2012-11-08
PMN K091763 | HTN Structure Medical, LLC	MABS	2012-11-08
PMN K080280 | HWC Structure Medical, LLC	SUBTALAR	2012-11-08
PMN K080083 | MAX Structure Medical, LLC	INTREPID SPINAL SYSTEM	2012-11-08
PMN K073285 | OVE Structure Medical, LLC	PEEK PREVAIL CERVICAL INTERBODY DEVICE	2012-11-08
PMN K070173 | MQP Structure Medical, LLC	VERTE-STACK SPINAL SYSTEM	2012-11-08
PMN K052747 | NQP Structure Medical, LLC	CD HORIZON SPINAL SYSTEM	2012-11-08
PMN K052747 | NKB Structure Medical, LLC	CD HORIZON SPINAL SYSTEM	2012-11-08
PMN K052747 | MNI Structure Medical, LLC	CD HORIZON SPINAL SYSTEM	2012-11-08
PMN K052747 | MNH Structure Medical, LLC	CD HORIZON SPINAL SYSTEM	2012-11-08
PMN K052747 | KWQ Structure Medical, LLC	CD HORIZON SPINAL SYSTEM	2012-11-08
PMN K052747 | KWP Structure Medical, LLC	CD HORIZON SPINAL SYSTEM	2012-11-08
PMN K052261 | MQP Structure Medical, LLC	VERTE-STACK SPINAL SYSTEM	2012-11-08
NBH Structure Medical, LLC	ACCESSORIES, ARTHROSCOPIC	2012-11-08
LXH Structure Medical, LLC	ORTHOPEDIC MANUAL SURGICAL INSTRUMENT	2012-11-08
HXX Structure Medical, LLC	SCREWDRIVER	2012-11-08
HXW Structure Medical, LLC	BENDER	2012-11-08
HXP Structure Medical, LLC	INSTRUMENT, BENDING OR CONTOURING	2012-11-08
HXC Structure Medical, LLC	WRENCH	2012-11-08
HXB Structure Medical, LLC	PROBE	2012-11-08
HWX Structure Medical, LLC	Tap, 6.0MM	2012-11-08
HWX Structure Medical, LLC	Tap, 5.5MM	2012-11-08
HWX Structure Medical, LLC	Tap, 5.0MM	2012-11-08
HWX Structure Medical, LLC	Tap, 4.5MM	2012-11-08
HWX Structure Medical, LLC	Tap, 4.0MM	2012-11-08
HWX Structure Medical, LLC	Tap, 3.5MM	2012-11-08
HWX Structure Medical, LLC	Tap, 3.0MM	2012-11-08
HWX Structure Medical, LLC	TAP, BONE	2012-11-08
HWX Structure Medical, LLC	Cannulated 8MM Tap	2012-11-08
HWX Structure Medical, LLC	Cannulated 7MM Tap	2012-11-08
HWX Structure Medical, LLC	4.5MM Cortical Tap	2012-11-08
HWT Structure Medical, LLC	TEMPLATE	2012-11-08
HWN Structure Medical, LLC	INSTRUMENT, COMPRESSION	2012-11-08
HWJ Structure Medical, LLC	AWL	2012-11-08
HTW Structure Medical, LLC	BIT, DRILL	2012-11-08
HTW Structure Medical, LLC	BIT, DRILL	2012-11-08
HTW Structure Medical, LLC	3.2MM Cannulated Drill, Delta	2012-11-08
HTW Structure Medical, LLC	3.2MM Cannulated Drill, Delta	2012-11-08
HTO Structure Medical, LLC	REAMER	2012-11-08
HTC Structure Medical, LLC	PLIERS, SURGICAL	2012-11-08
GAD Structure Medical, LLC	RETRACTOR	2012-11-08
FZX Structure Medical, LLC	GUIDE, SURGICAL, INSTRUMENT	2012-11-08
FZX Structure Medical, LLC	3.2MM Threaded Drill Guide	2012-11-08
FSM Structure Medical, LLC	TRAY, SURGICAL, INSTRUMENT	2012-11-08
PMN K041197 | MQP Structure Medical, LLC	VERTE-STACK SPINAL SYSTEM	2012-11-02
PMN K021791 | MQP Structure Medical, LLC	VERTE-STACK SPINAL SYSTEM	2012-11-02