QCKFIX SCRW,TI,CANN.,PT,2.4X 32MM

Registration Details

Registration Name: 3D MEDICAL MANUFACTURING, INC. (dba Tecomet)
Registration Number: 3001239363
FEI Number: 3001239363
Status: Active
Expiry Year: 2025
Initial Importer: No
Address: 1006 West 15th Street
City: Riviera Beach
State: FL
ZIP: 33404
Country: US

Regulatory Submissions

510(k) Number: K143614

Owner / Operator

Firm Name: 3D Medical Manufacturing, inc. DBA Tecomet
Operator Number: 10043250
Address: 2001 Congress Avenue
City: Riviera Beach
State: FL
Postal Code: 33404
Country: US
Correspondent: Vanesa Fields

Products

Device Name	Product Code	Device Class	Medical Specialty	Exempt	Created
Screw, Fixation, Bone	HWC	Class 2	Orthopedic	No	2019-09-16

Proprietary Names

QCKFIX SCRW,TI,CANN.,PT,2.4X 32MM LO-PRO LOCK SCRW,SS 3.5X 46MM LO-PRO SCRW TM,SS 3.5X 46MMCORT LO-PRO LOCK SCRW,SS 3.5X 28MM LOCKING SCREW, TITANIUM 3.5MM X 38MM QCKFIX SCRW,TI CANN ST,CANC.,4X 40MM LOW PROF SCRW,SS 4X 30MMCANN LNG THD LO-PRO SCRW,TI,4MMX 20MM LO-PRO LOCK SCRW,SS 3.5X 20MM LOCKING SCREW, TITANIUM 3.5MM X 22MM QCKFIX SCRW,TI,CANN ST,CANC.,4X 28MM QCKFIX SCRW,TI,CANN.,PT,2.4X 20MM LO-PRO LOCK SCRW,SS 3.5X 24MM LO-PRO SCRW,TI,4MMX 34MM QCKFIX SCRW,TI,CANN ST,CANC.,4X 32MM LO-PRO SCRW TM,SS 3.5X 36MMCORT LOW PROF SCRW,SS 4X 38MMCANN LNG THD LO-PRO SCRW TM,SS 3.5X 16MMCORT LO-PRO LOCK SCRW,SS 3.5X 32MM QCKFIX SCRW,TI,CANN ST,CANC.,4X 56MM QCKFIX SCRW,TI,CANN ST,CANC.,4X 16MM QUICKFIX SCREW, TI, CANN., PT 2.4 X 14MM LOCKING SCREW, TITANIUM 3.5MM X 36MM LO-PRO LOCK SCRW,SS 3.5X 26MM LOW PROF SCRW,SS 4X 55MMCANN LNG THD LO-PRO LOCK SCRW,SS 3.5X 48MM QCKFIX SCRW,TI,CANN.,PT,2.4X 16MM LO-PRO SCRW TM,SS 3.5X 40MMCORT LOCKING SCREW, TITANIUM 3.5MM X 26MM LO-PRO SCRW TM,SS 3.5X 44MMCORT LOW PROFILE SCREW, 2.4 X 14MM, CORTEX QUICKFIX SCREW, TI CANN., PT, 2.4 X 10MM LOW PROF SCRW,SS 4X 40MMCANN LNG THD LO-PRO SCRW,TI,4MMX 28MM LOCKING SCREW, TITANIUM 3.5MM X 32MM LO-PRO SCRW,TI,3.5MMX 44MM QCKFIX SCRW,TI,CANN ST,CANC.,4X 22MM LOW PROFILE SCREW, 2.4 X 16MM, CORTEX LOCKING SCREW, TITANIUM 3.5MM X 16MM LO-PRO LOCK SCRW,SS 3.5X 10MM LO-PRO SCRW TM,SS 3.5X 28MMCORT LO-PRO SCRW,TI,3.5MMX 22MM LO-PRO SCRW,TI,3.5MMX 34MM QCKFIX SCRW,TI,CANN ST,CANC.,4X 38MM QUICKFIX SCREW, TI CANN., PT, 2.4 X 34MM LOW PROF SCRW,SS 4X 50MMCANN,SHT THD LO-PRO SCRW,TI,3.5MMX 20MM LO-PRO SCRW TM,SS 3.5X 45MMCORT LO-PRO LOCK SCRW,SS 3.5X 40MM LOW PROFILE SCREW, 2.4 X 26MM, CORTEX LO-PRO SCRW,TI,3.5MMX 28MM LOW PROF SCRW,SS 4X 60MMCANN LNG THD LO-PRO SCRW,TI,4MMX 24MM LO-PRO SCRW,TI,3.5MMX 18MM QUICKFIX SCREW, TI, CANN., PT 2.4 X 8MM LOW PROFILE SCREW, 2.4 X 12MM, CORTEX QCKFIX SCRW,TI,CANN ST,CANC.,4X 20MM LO-PRO LOCK SCRW,SS 3.5X 16MM LO-PRO SCRW,TI,3.5MMX 30MM LOCKING SCREW, TITANIUM 3.5MM X 24MM QCKFIX SCRW,TI,CANN ST,CANC.,4X 52MM LO-PRO SCRW,TI,3.5MMX 26MM LO-PRO SCRW TM,SS 3.5X 10MMCORT LO-PRO SCRW,TI,3.5MMX 14MM LO-PRO SCRW,TI,4MMX 18MM LOW PROF SCRW,SS 4X 40MMCANN,SHT THD LO-PRO LOCK SCRW,TI,3MMX 16MM LOW PROF SCRW,SS 4X 42MMCANN LNG THD LO-PRO LOCK SCRW,SS 3.5X 14MM QCKFIX SCRW,TI,CANN ST,CANC.,4X 44MM LO-PRO LOCK SCRW,SS 3.5X 30MM LO-PRO LOCK SCRW,SS 3.5X 38MM LO-PRO LOCK SCRW,SS 3.5X 42MM LO-PRO SCRW TM,SS 3.5X 75MMCORT LOW PROFILE SCREW, 2.4 X 34MM, CORTEX LOW PROF SCRW,SS 4X 46MMCANN,SHT THD LOW PROF SCRW,SS 4X 44MMCANN LNG THD LOW PROF SCRW,SS 4X 55MMCANN,SHT THD LO-PRO SCRW TM,SS 3.5X 60MMCORT LO-PRO SCRW TM,SS 3.5X 42MMCORT QCKFIX SCRW,TI,CANN.,PT,2.4X 12MM LO-PRO SCRW TM,SS 3.5X 70MMCORT LO-PRO SCRW,TI,4MMX 22MM LO-PRO SCRW,TI,4MMX 44MM LO-PRO LOCK SCRW,SS 3.5X 34MM LO-PRO SCRW,TI,3.5MMX 36MM LO-PRO SCRW,TI,4MMX 30MM LOW PROF SCRW,SS 4X 35MMCANN,SHT THD LO-PRO SCRW TM,SS 3.5X 34MMCORT LO-PRO SCRW TM,SS 3.5X 80MMCORT LO-PRO SCRW,TI,3.5MMX 24MM QCKFIX SCRW,TI,CANN.,PT,2.4X 22MM QCKFIX SCRW,TI,CANN ST,CANC.,4X 58MM LOW PROFILE SCREW, 2.4 X 40MM, CORTEX LOW PROF SCRW,SS 4X 45MMCANN,SHT THD LO-PRO LOCK SCRW,TI,3MMX 18MM QCKFIX SCRW,TI,CANN.,PT,2.4X 18MM LO-PRO SCRW TM,SS 3.5X 55MMCORT LOW PROF SCRW,SS 4X 35MMCANN LNG THD LOW PROF SCRW,SS 4X 34MMCANN,SHT THD LOW PROF SCRW,SS 4X 32MMCANN,SHT THD LOW PROFILE SCREW, 2.4 X 8MM, CORTEX QCKFIX SCRW,TI,CANN ST,CANC.,4X 60MM LO-PRO SCRW,TI,3.5MMX 40MM LO-PRO LOCK SCRW,SS 3.5X 18MM LO-PRO SCRW,TI,4MMX 40MM LOW PROFILE SCREW, 2.4 X 36MM, CORTEX LOW PROFILE SCREW, 2.4 X 28MM, CORTEX LOCKING SCREW, TITANIUM 3.5MM X 14MM LO-PRO SCRW,TI,4MMX 42MM LOCKING SCREW, TITANIUM 3.5MM X 30MM QCKFIX SCRW,TI,CANN ST,CANC.,4X 54MM LO-PRO SCRW,TI,3.5MMX 32MM LO-PRO LOCK SCRW,TI,3MMX 10MM LOW PROF SCRW,SS 4X 45MMCANN LNG THD LOW PROF SCRW,SS 4X 30MMCANN,SHT THD LO-PRO SCRW,TI,4MMX 14MM QCKFIX SCRW,TI,CANN.,PT,2.4X 24MM QCKFIX SCRW,TI,CANN ST,CANC.,4X 18MM LO-PRO SCRW,TI,4MMX 36MM LO-PRO SCRW TM,SS 3.5X 22MMCORT LOW PROF SCRW,SS 4X 48MMCANN LNG THD LO-PRO SCRW TM,SS 3.5X 20MMCORT LOW PROFILE SCREW, 2.4 X 38MM, CORTEX LOW PROFILE SCREW, 2.4 X 20MM, CORTEX QCKFIX SCRW,TI,CANN.,PT,2.4X 30MM LO-PRO LOCK SCRW,SS 3.5X 50MM LO-PRO LOCK SCRW,TI 3MMX 22MM LO-PRO LOCK SCRW,TI,3MMX 20MM QCKFIX SCRW,TI,CANN.,PT,2.4X 26MM LOW PROFILE SCREW, 2.4 X 24MM, CORTEX LO-PRO LOCK SCRW,TI,3MMX 24MM LOCKING SCREW, TITANIUM 3.5MM X 42MM LO-PRO SCRW,TI,3.5MMX 38MM LO-PRO SCRW TM,SS 3.5X 50MMCORT QCKFIX SCRW,TI,CANN.,PT,2.4X 36MM QCKFIX SCRW,TI,CANN.,PT,2.4X 28MM LOCKING SCREW, TITANIUM 3.5MM X 34MM LO-PRO LOCK SCRW,TI,3MMX 12MM LO-PRO SCRW TM,SS 3.5X 48MMCORT QCKFIX SCRW,TI,CANN ST,CANC.,4X 46MM LOCKING SCREW, TITANIUM 3.5MM X 44MM LOW PROF SCRW,SS 4X 38MMCANN,SHT THD LO-PRO SCRW,TI,4MMX 32MM LO-PRO LOCK SCRW,SS 3.5X 22MM QCKFIX SCRW,TI,CANN ST,CANC.,4X 14MM QCKFIX SCRW,TI,CANN ST,CANC.,4X 50MM LO-PRO SCRW TM,SS 3.5X 18MMCORT LOW PROF SCRW,SS 4X 44MMCANN,SHT THD LO-PRO SCRW TM,SS 3.5X 32MMCORT LOW PROF SCRW,SS 4X 48MMCANN,SHT THD QCKFIX SCRW,TI,CANN ST,CANC.,4X 24MM LOW PROF SCRW,SS 4X 50MMCANN LNG THD LO-PRO LOCK SCRW,SS 3.5X 44MM LO-PRO SCRW TM,SS 3.5X 30MMCORT LO-PRO LOCK SCRW,TI,3MMX 14MM QCKFIX SCRW,TI,CANN ST,CANC.,4X 36MM LOW PROFILE SCREW, 2.4 X 10MM, CORTEX LOCKING SCREW, TITANIUM 3.5MM X 20MM LOCKING SCREW, TITANIUM 3.5MM X 28MM LO-PRO SCRW,TI,4MMX 26MM LOW PROFILE SCREW, 2.4 X 18MM, CORTEX QCKFIX SCRW,TI,CANN ST,CANC.,4X 34MM LO-PRO SCRW,TI,4MMX 16MM LOW PROF SCRW,SS 4X 36MMCANN,SHT THD LO-PRO SCRW,TI,3.5MMX 16MM LOW PROF SCRW,SS 4X 46MMCANN LNG THD LOW PROF SCRW,SS 4X 60MMCANN,SHT THD LO-PRO LOCK SCRW,SS 3.5X 12MM LO-PRO SCRW,TI,3.5MMX 42MM QCKFIX SCRW,TI,CANN ST,CANC.,4X 30MM LO-PRO SCRW TM,SS 3.5X 12MMCORT LOW PROF SCRW,SS 4X 36MMCANN LNG THD LO-PRO SCRW TM,SS 3.5X 26MMCORT LOW PROFILE SCREW, 2.4 X 30MM, CORTEX LO-PRO SCRW TM,SS 3.5X 24MMCORT LO-PRO SCRW TM,SS 3.5X 38MMCORT LO-PRO SCRW TM,SS 3.5X 14MMCORT QCKFIX SCRW,TI CANN ST,CANC.,4X 42MM QCKFIX SCRW,TI,CANN ST,CANC.,4X 48MM LO-PRO SCRW TM,SS 3.5X 35MMCORT LOW PROF SCRW,SS 4X 42MMCANN,SHT THD LO-PRO SCRW TM,SS 3.5X 65MMCORT LOW PROF SCRW,SS 4X 32MMCANN LNG THD LOW PROFILE SCREW, 2.4 X 22MM, CORTEX LOW PROFILE SCREW, 2.4 X 32MM, CORTEX LO-PRO SCRW,TI,4MMX 38MM LOCKING SCREW, TITANIUM 3.5MM X 40MM LO-PRO LOCK SCRW,SS 3.5X 36MM LOCKING SCREW, TITANIUM 3.5MM X 18MM LOW PROF SCRW,SS 4X 34MMCANN LNG THD

Establishment Types

Manufacture Medical Device for Another Party (Contract Manufacturer)