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
- [email protected]
- Phone
- 786 2585633
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Passer, Wire, Orthopedic | HXI | Class 1 | Orthopedic | No | 2020-08-12 |
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2023-02-23 |
| Dissector, Surgical, General & Plastic Surgery | GDI | Class 1 | General, Plastic Surgery | No | 2022-05-09 |
| Instrument, Bending Or Contouring | HXP | Class 1 | Orthopedic | No | 2020-08-12 |
| Clamp | HXD | Class 1 | General, Plastic Surgery | No | 2022-05-10 |
| Tap, Bone | HWX | Class 1 | Orthopedic | No | 2022-05-10 |
| Wrench | HXC | Class 1 | Orthopedic | No | 2022-05-10 |
| Holder, Needle; Orthopedic | HXK | Class 1 | Orthopedic | No | 2020-08-12 |
| Handle, Scalpel | GDZ | Class 1 | General, Plastic Surgery | No | 2022-05-09 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2020-08-12 |
| Instrument, Compression | HWN | Class 1 | Orthopedic | No | 2020-08-12 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2022-03-31 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2022-03-31 |
| Gauge, Depth | HTJ | Class 1 | Orthopedic | No | 2022-05-10 |
| Skid, Bone | HWO | Class 1 | Orthopedic | No | 2020-08-12 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2020-08-12 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2020-08-12 |
| Elevator | HTE | Class 1 | General, Plastic Surgery | No | 2022-05-10 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2020-08-02 |
| Driver, Wire, And Bone Drill, Manual | DZJ | Class 2 | Dental | No | 2023-11-07 |
| Mallet | HXL | Class 1 | General, Plastic Surgery | No | 2022-05-10 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 2022-05-10 |
| Impactor | HWA | Class 1 | Orthopedic | No | 2022-05-10 |
| Plate, Bone | JEY | Class 2 | Dental | No | 2021-11-08 |
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