FDA Registration Active 🇨🇴 Colombia

INDUSTRIAS MEDICAS SAMPEDRO S.A.S

Reg #: 3004187715 · FEI: 3004187715 · Expires 2026
Products
24
Proprietary Names
228
Establishment Types
3
Classifications
24

Registration Details

Registration Name
INDUSTRIAS MEDICAS SAMPEDRO S.A.S
Registration Number
3004187715
FEI Number
3004187715
Status
Active
Expiry Year
2026
Initial Importer
No
Address
Carrera 47 100 Sur 40 Bodega 14
City
La Estrella Antioquia
Country
CO

Regulatory Submissions

510(k) Number
K220199

Owner / Operator

Firm Name
INDUSTRIAS MEDICAS SAMPEDRO S.A.S
Operator Number
10062588
Address
Carrera 47 100 Sur 40 Bodega 14
City
La Estrella
State
Antioquia
Postal Code
055468
Country
CO
Correspondent
Maritza Buitrago-Vasquez

US Agent

Business Name
FLEXBLUE MARKETS LLC
Contact Name
BEATRIZ RESTREPO
Address
183 Madeira Ave
City
Coral Gables
State
FL
ZIP
33134
Country
US
Phone
786 2585633

Products

Device Name Product Code
Passer, Wire, Orthopedic HXI
System, Image Processing, Radiological LLZ
Dissector, Surgical, General & Plastic Surgery GDI
Instrument, Bending Or Contouring HXP
Clamp HXD
Tap, Bone HWX
Wrench HXC
Holder, Needle; Orthopedic HXK
Handle, Scalpel GDZ
Screwdriver HXX
Instrument, Compression HWN
Screw, Fixation, Bone HWC
Plate, Fixation, Bone HRS
Gauge, Depth HTJ
Skid, Bone HWO
Bit, Drill HTW
Guide, Surgical, Instrument FZX
Elevator HTE
Orthopedic Manual Surgical Instrument LXH
Driver, Wire, And Bone Drill, Manual DZJ
Mallet HXL
Forceps HTD
Impactor HWA
Plate, Bone JEY

Proprietary Names

KIRSCHNER wire 1.5mm X 150mm KIRSCHNER wire 1mm X 150mm KIRSCHNER wire with threaded tip 1mm X 150mm STEINMANN wire 2MM X 150MM Kirschner Wires 1,5mm Kirschner Wires 2,0mm TECHFIT Diagnostic Models Freer Dissector 18cm Hurd Dissector Bending iron for Affinity plate Bending Iron for plate Vosburg periarticular reduction clamp Handle With Quick Coupling Tap - AO Shaft ?3.5mm with Pitch 1.25mm used for ?3.5mm cortical screw Wrench Weitlaner-Wullstein Wound spreader blunt 3x3 teeth 14cm, Opening 50mm Alm wound spreaders, 10 cm, 4, blunt West wound Spreader 3x3 teeth 13cm, Opening 60mm Reduction Forceps with ratchet, 145mm Reduction Forceps with points, 135mm Bone Holding Forceps, 16cm Reduction Forcep With points, Speed lock Reduction Forceps - Termite Stagbeetle T-Handle with Quick Coupling Jacobs chuck with T-handle Cannulated screwdriver hexalobe T8 AO Handle for torque limiting 0,8 NM Drive Handle AO-M Screwdriver hexalobe T8 AO T15 short screwdriver bit Screwdriver Hexalobe 4,0mm 2N M Handle for torque limiting T15 long screwdriver bit Inge 16 cm 3.5mm Self Tapping Locking Screw, Pentalock, 44mm Lateral Proximal Tibia Plate -6H - Right 3.5mm Self Tapping Locking Screw, Pentalock, 40mm 3.5mm Self-Tapping Cortex Screws, TI, 80mm Lateral Proximal Tibia Plate -10H - Left 3.5mm Self-Tapping Cortex Screws, TI, 55mm Medial Proximal Tibia Plate -18H - Right Medial Proximal Tibia Plate -6H - Left Medial Proximal Tibia Plate -12H - Right 3.5mm Self-Tapping Cortex Screws, TI, 65mm Lateral Proximal Tibia Plate -18H - Right Medial Proximal Tibia Plate -2H - Right Lateral Proximal Tibia Plate -4H - Right 3.5mm Self Tapping Locking Screw, Pentalock, 36mm 3.5mm Self-Tapping Cortex Screws, TI, 42mm 3.5mm Self Tapping Locking Screw, Pentalock, 90mm 3.5mm Self Tapping Locking Screw, Pentalock, 85mm 3.5mm Self Tapping Locking Screw, Pentalock, 28mm Lateral Proximal Tibia Plate -16H - Right Medial Proximal Tibia Plate -8H - Left Lateral Proximal Tibia Plate -8H - Left 3.5mm Self-Tapping Cortex Screws, TI, 34mm 3.5mm Self Tapping Locking Screw, Pentalock, 55mm 3.5mm Self-Tapping Cortex Screws, TI, 90mm 3.5mm Self-Tapping Cortex Screws, TI, 50mm Medial Proximal Tibia Plate -8H - Right 3.5mm Self Tapping Locking Screw, Pentalock, 42mm Medial Proximal Tibia Plate -16H - Left 3.5mm Self Tapping Locking Screw, Pentalock, 65mm Medial Proximal Tibia Plate -18H - Left 3.5mm Self-Tapping Cortex Screws, TI, 30mm Lateral Proximal Tibia Plate -2H - Right 3.5mm Self-Tapping Cortex Screws, TI, 38mm Lateral Proximal Tibia Plate -6H - Left Lateral Proximal Tibia Plate -18H - Left 3.5mm Self-Tapping Cortex Screws, TI, 75mm 3.5mm Self-Tapping Cortex Screws, TI, 18mm 3.5mm Self-Tapping Cortex Screws, TI, 22mm 3.5mm Self-Tapping Cortex Screws, TI, 70mm Lateral Proximal Tibia Plate -2H - Left Medial Proximal Tibia Plate -16H - Right Medial Proximal Tibia Plate -4H - Left AFFINITY 3.5mm Self Tapping Locking Screw, Pentalock, 38mm Medial Proximal Tibia Plate -2H - Left 3.5mm Self-Tapping Cortex Screws, TI, 40mm 3.5mm Self Tapping Locking Screw, Pentalock, 48mm Lateral Proximal Tibia Plate -10H - Right 3.5mm Self Tapping Locking Screw, Pentalock, 95mm 3.5mm Self Tapping Locking Screw, Pentalock, 70mm 3.5mm Self-Tapping Cortex Screws, TI, 95mm Lateral Proximal Tibia Plate -14H - Left Medial Proximal Tibia Plate -6H - Right Lateral Proximal Tibia Plate -8H - Right Lateral Proximal Tibia Plate -4H - Left 3.5mm Self-Tapping Cortex Screws, TI, 44mm 3.5mm Self Tapping Locking Screw, Pentalock, 32mm Medial Proximal Tibia Plate -10H - Right Medial Proximal Tibia Plate -4H - Right 3.5mm Self Tapping Locking Screw, Pentalock, 22mm 3.5mm Self-Tapping Cortex Screws, TI, 26mm 3.5mm Self-Tapping Cortex Screws, TI, 46mm 3.5mm Self Tapping Locking Screw, Pentalock, 34mm Lateral Proximal Tibia Plate -12H - Left 3.5mm Self Tapping Locking Screw, Pentalock, 24mm 3.5mm Self Tapping Locking Screw, Pentalock, 26mm 3.5mm Self Tapping Locking Screw, Pentalock, 46mm Medial Proximal Tibia Plate -14H - Left Lateral Proximal Tibia Plate -16H - Left 3.5mm Self-Tapping Cortex Screws, TI, 48mm 3.5mm Self Tapping Locking Screw, Pentalock, 60mm 3.5mm Self-Tapping Cortex Screws, TI, 36mm 3.5mm Self Tapping Locking Screw, Pentalock, 80mm 3.5mm Self Tapping Locking Screw, Pentalock, 50mm Lateral Proximal Tibia Plate -12H - Right 3.5mm Self-Tapping Cortex Screws, TI, 60mm Medial Proximal Tibia Plate -12H - Left 3.5mm Self-Tapping Cortex Screws, TI, 32mm Medial Proximal Tibia Plate -14H - Right 3.5mm Self Tapping Locking Screw, Pentalock, 75mm 3.5mm Self Tapping Locking Screw, Pentalock, 18mm 3.5mm Self-Tapping Cortex Screws, TI, 85mm 3.5mm Self-Tapping Cortex Screws, TI, 20mm 3.5mm Self-Tapping Cortex Screws, TI, 24mm Medial Proximal Tibia Plate -10H - Left 3.5mm Self Tapping Locking Screw, Pentalock, 30mm 3.5mm Self-Tapping Cortex Screws, TI, 28mm Depth Gauge 110 mm Depth Gauge 3,5mm Periosteal Elevator, small curved blade Hohmann Retractor 8mm Sharp-Hook Hohmann Retractor 24cm Hohmann Retractor 28.5cm Senn-Miller Retractor 16cm (blunt) Drill Bit 2,5 mm x 160/135mm Drill bit 2 mm x 125/100mm, AO Drill Bit 2 mm x 100/75mm, AO Drill 2 mm Short Drill Bit 2,8mm Cannulated drill 2MM AO Drill Bit 3.5mm X 195mm Long Drill Bit 2,8mm Locking drill guide 2 with measuring scale Drill Bit 2.5 Mm, AO Quick Coupling Drill bit 2.5mm X 160/135mm Drill Bit ?2.5 2.5mm FT pentalock cortex screw, 20mm- 2.5mm FT cortex screw, 14mm Distal ulnar T-plates, 6H Extra-articular distal radius plate, wide, right, 3H 2.5mm FT cannulated cortex screw, pentalock, 30mm- 2.5mm FT pentalock cortex screw, 24mm- 2.5mm FT cortex screw, 16mm 2.5mm FT pentalock cortex screw, 16mm- 2mm pentalock peg, 24mm- 2.5mm FT pentalock cortex screw, 10mm- 2.5mm FT cannulated cortex screw, pentalock, 20mm- 2mm pentalock peg,10mm- 2.5mm FT cortex screw, 28mm Extra-articular distal radius plate, intermediate, left, 3H Radius styloid plates, straight, 4H 2mm pentalock peg, 18mm- 2.5mm FT cannulated cortex screw, pentalock, 24mm- AFFINITY - Variable Angle Distal Radius System 2.5mm FT pentalock cortex screw, 28mm- 2.5mm FT pentalock cortex screw, 12mm- 2mm pentalock peg, 14mm- 2.5mm FT pentalock cortex screw, 18mm- 2.5mm PT cannulated cortex screw, 30mm 2.5mm FT cortex screw, 18mm Extra-articular distal radius plate, narrow, left, 3H Distal dorso-ulnar and dorso-radial L-plates, right, 4H 2mm pentalock peg, 12mm- 2.5mm PT cannulated cortex screw, 20mm 2.5mm FT cannulated cortex screw, pentalock, 22mm- 2.5mm PT cannulated cortex screw, 28mm 2mm pentalock peg, 30mm- 2mm pentalock peg, 28mm- Extra-articular distal radius plate, wide, left, 3H Extra-articular distal radius plate, narrow, right, 3H 2.5mm FT cannulated cortex screw, pentalock, 28mm- Extra-articular distal radius plate, narrow, right, 2H Extra-articular distal radius plate, intermediate, right, 7H 2.5mm FT cortex screw, 30mm 2.5mm FT cortex screw, 26mm 2.5mm FT pentalock cortex screw, 26mm- 2.5mm FT cortex screw, 22mm 2.5mm PT cannulated cortex screw, 24mm 2.5mm FT cortex screw, 20mm Distal dorso-ulnar and dorso-radial L-plates, right, 6H Extra-articular distal radius plate, intermediate, right, 2H Extra-articular distal radius plate, intermediate, left, 2H 2.5mm FT pentalock cortex screw, 14mm- Distal ulnar T-plates, 4H Extra-articular distal radius plate, intermediate, left, 7H Distal dorso-ulnar and dorso-radial L-plates, left, 6H 2.5mm FT cortex screw, 10mm 2.5mm FT pentalock cortex screw, 22mm- 2.5mm FT cortex screw, 24mm Distal dorso-ulnar and dorso-radial L-plates, left, 4H 2.5mm FT pentalock cortex screw, 30mm- 2.5mm FT cortex screw, 12mm Extra-articular distal radius plate, narrow, left, 2H Extra-articular distal radius plate, intermediate, right, 3H 2.5mm PT cannulated cortex screw, 26mm 2.5mm FT cannulated cortex screw, pentalock, 26mm- 2.5mm PT cannulated cortex screw, 22mm 2mm pentalock peg, 26mm- 2mm pentalock peg, 16mm- 2mm pentalock peg, 20mm- Radius styloid plates, straight, 6H 2mm pentalock peg, 22mm- Locking peg guide Insert drill Sleeve ?2.5-?3.5 Double Drill Guide Long locking drill sleeve 2,9mm Screw guide sleeve 5mm Variable angle drill guide Short locking drill sleeve 2,9mm Cobb Elevator Affinity - Variable Angle Distal Radius Instruments Length Gauge with cannulated 1 mm Styloid hole variable angle drill guide Plate wide centralizer Plate narrow centralizer Plate intermediates centralizer Distracter 24cm Screw Length Gauge Techfit Disrp® System Cottle mallet ?30mm Termite Stagbeetle Bone Impactor 6mm TECHFIT Patient-Specific Maxillofacial System

Establishment Types

Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer) Complaint File Establishment per 21 CFR 820.198