Data / Medical devices / Colombia / Industrias Medicas Sampedro S.A.S

Industrias Medicas Sampedro S.A.S: FDA-registered device maker in La Estrella Antioquia, Colombia, 2 510(k) clearances

Name: Industrias Medicas Sampedro S.A.S FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Industrias Medicas Sampedro S.A.S is registered with the FDA (registration 3004187715) in La Estrella Antioquia, Colombia. It lists 21 device types. The FDA files 2 510(k) clearances under its listings, the newest dated March 21, 2022. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3004187715
Address: Carrera 47 100 Sur 40 Bodega 14, La Estrella Antioquia, Colombia, 055468
Owner or operator: INDUSTRIAS MEDICAS SAMPEDRO S.A.S (10062588)
Roles: Complaint file establishment, Manufacturer
First device listed: February 18, 2020
Registered through: 2026
Brand names listed: 2.5mm FT cannulated cortex screw, pentalock, 20mm-, 2.5mm FT cannulated cortex screw, pentalock, 22mm-, 2.5mm FT cannulated cortex screw, pentalock, 24mm-, 2.5mm FT cannulated cortex screw, pentalock, 26mm-, 2.5mm FT cannulated cortex screw, pentalock, 28mm-, 2.5mm FT cannulated cortex screw, pentalock, 30mm-, 2.5mm FT cortex screw, 10mm, 2.5mm FT cortex screw, 12mm and more

Devices it lists

Device	Product code	Class	Role	Source
Bit, Drill	HTW	1	Manufacturer	accessdata.fda.gov
Clamp	HXD	1	Manufacturer	accessdata.fda.gov
Dissector, Surgical, General & Plastic Surgery	GDI	1	Manufacturer	accessdata.fda.gov
Elevator	HTE	1	Manufacturer	accessdata.fda.gov
Forceps	HTD	1	Manufacturer	accessdata.fda.gov
Gauge, Depth	HTJ	1	Manufacturer	accessdata.fda.gov
Guide, Surgical, Instrument	FZX	1	Manufacturer	accessdata.fda.gov
Handle, Scalpel	GDZ	1	Manufacturer	accessdata.fda.gov
Holder, Needle; Orthopedic	HXK	1	Manufacturer	accessdata.fda.gov
Impactor	HWA	1	Manufacturer	accessdata.fda.gov
Instrument, Bending Or Contouring	HXP	1	Manufacturer	accessdata.fda.gov
Instrument, Compression	HWN	1	Manufacturer	accessdata.fda.gov
Mallet	HXL	1	Manufacturer	accessdata.fda.gov
Orthopedic Manual Surgical Instrument	LXH	1	Manufacturer	accessdata.fda.gov
Passer, Wire, Orthopedic	HXI	1	Manufacturer	accessdata.fda.gov
Plate, Fixation, Bone	HRS	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Screw, Fixation, Bone	HWC	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Screwdriver	HXX	1	Manufacturer	accessdata.fda.gov
Skid, Bone	HWO	1	Manufacturer	accessdata.fda.gov
Tap, Bone	HWX	1	Manufacturer	accessdata.fda.gov
Wrench	HXC	1	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
March 21, 2022	K220199	AFFINITY Proximal Tibia System	HRS	Substantially Equivalent	Techfit Digital Surgery, Inc.	accessdata.fda.gov
September 16, 2019	K191641	AFFINITY Variable Angle Distal Radius System, AFFINITY Variable Angle Distal Radius Plates, AFFINITY Variable Angle Distal Radius Screws	HRS	Substantially Equivalent	Industrias Medicas Sampedro S.A.S	accessdata.fda.gov

Compare with other makers

Updated March 21, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.