Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004187715

FEI Number

3004187715

Entity Name

INDUSTRIAS MEDICAS SAMPEDRO S.A.S

City/State/Country

La Estrella Antioquia, CO

Establishment Address

Carrera 47 100 Sur 40 Bodega 14, La Estrella Antioquia 055468, CO

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

INDUSTRIAS MEDICAS SAMPEDRO S.A.S (Owner Number: 10062588)

Owner / Operator Contact Address

Carrera 47 100 Sur 40 Bodega 14, La Estrella, CO-ANT 055468, CO

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered 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 drill guide 2 with measuring scale 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 Variable angle drill guide Plate narrow centralizer Plate intermediates centralizer Distracter 24cm Screw Length Gauge

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HXI	Passer, Wire, Orthopedic	Orthopedic	Class 1	888.4540	2020-08-12
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2023-02-23
GDI	Dissector, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2022-05-09
HXP	Instrument, Bending Or Contouring	Orthopedic	Class 1	888.4540	2020-08-12
HXD	Clamp	General, Plastic Surgery	Class 1	878.4800	2022-05-10
HWX	Tap, Bone	Orthopedic	Class 1	888.4540	2022-05-10
HXC	Wrench	Orthopedic	Class 1	888.4540	2022-05-10
HXK	Holder, Needle; Orthopedic	Orthopedic	Class 1	888.4540	2020-08-12
GDZ	Handle, Scalpel	General, Plastic Surgery	Class 1	878.4800	2022-05-09
HXX	Screwdriver	Orthopedic	Class 1	888.4540	2020-08-12
HWN	Instrument, Compression	Orthopedic	Class 1	888.4540	2020-08-12
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2022-03-31
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2022-03-31
HTJ	Gauge, Depth	Orthopedic	Class 1	888.4300	2022-05-10
HWO	Skid, Bone	Orthopedic	Class 1	888.4540	2020-08-12
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2020-08-12
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2020-02-18
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2020-02-18
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2020-08-12
HTE	Elevator	General, Plastic Surgery	Class 1	878.4800	2022-05-10
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2020-08-02

Official Correspondent

Maritza Buitrago-Vasquez

US Agent Details

BEATRIZ RESTREPO Business: FLEXBLUE MARKETS LLC Email: info@flexbluemarkets.com Phone: (786) 2585633

Related Public Records

Same Entity

INDUSTRIAS MEDICAS SAMPEDRO S.A.S

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K080013	Agfa Healthcare Corporation	REGISTRATION AND FUSION	2008-01-17
K042221	Barco NV Barcoview	CORONIS 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM	2004-12-30
K092915	Cedara Software Corp.	CEDARA WEBACCESS, MODEL: 2.4	2010-06-23
K961871	Siemens Medical Solutions USA, Inc.	FLOUROSPOT T.O.P.	1996-07-31
K122260	Aycan Digitalsysteme GmbH	AYCAN MOBILE	2012-09-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0012-2022	GE Healthcare, LLC	2	Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system
Z-0023-2016	GE Healthcare	2	Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.
Z-0030-2026	CHANGE HEALTHCARE CANADA COMPANY	2	Change Healthcare Radiology Solutions software version 14.2.2
Z-0032-2012	Philips Healthcare Inc.	2	MDC PACS - release R2.3 SP1 . Phillips Healthcare Andover, Massachusetts A software application that is used for receiving, managing, archiving, distributing and recording medical images onto portable digital media (including but not limited to Compact Disk and DVD).
Z-0033-2007	AGFA Corp.	2	IMPAX 5.2 Systems with CAD Capability (Computer Assisted Diagnosis)

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004187715. Last updated year: 2026. Please use registration number 3004187715 when referencing this establishment in official correspondence.