Materialise Colombia S.A.S (manufacturer, Medellin Antioquia, CO): 3 new FDA device listings, incl. shoulder arthroplasty implantation system

Materialise Colombia S.A.S (Medellin Antioquia, Colorado): 3 new FDA device listings, incl. shoulder arthroplasty implantation system. Its amount of 3 is above the median of 1 (77th percentile). Dated 120 days ago, it serves as a historical benchmark. Score 75/100. As of 2026-10-28, from openFDA device registration and listing endpoint (U.S. Food and Drug Administration).

Data as of · Compiled by Zalwin from openFDA device registration and listing endpoint (U.S. Food and Drug Administration)

amount: 3 · 77th percentile of 2,570 DeviceEstablishmentPulse records · 3.0x the median

Free preview: all 15 published fields of this record are shown below. Locked: 32 related CO DeviceEstablishmentPulse records and the 5-column CSV export.

FieldValue
EstablishmentMaterialise Colombia S.A.S
Owner / operatorMaterialise N.V.
RoleManufacturer
Establishment typesManufacture Medical Device
LocationMedellin Antioquia, CO
New listings3
DevicesShoulder Arthroplasty Implantation System; Shoulder Prosthesis, Reverse Configuration; Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Product codesQHE, PHX, KWS
Device classesClass II
Medical specialtiesOrthopedic
Brand namesLima Personalized Surgical Instruments; Materialise Shoulder Guide and Models; Materialise Shoulder System; TruMatch Personalized Solutions Shoulder Guide; SurgiCase Shoulder Planner; AtlasPlan Shoulder System; Materialise Shoulder Planner; Materialise Glenoid Positioning System guides
First new listing2026-07-08
Latest new listing2026-07-08
FDA registration number3011724582
Registration expires2026-12-31
amount percentile77th of 2,570 (median 1, 3.0x median)
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CSV columns: Establishment · Role · New listings · Devices · Latest listing · official source URL

  • Source agency: openFDA device registration and listing endpoint (U.S. Food and Drug Administration)
  • Record date: 2026-07-08
  • Data refreshed: 2026-10-28
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LIVE PUBLIC DATA Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) · Last refreshed: Wed, 28 Oct 2026 20:51:27 GMT

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Peer benchmark and outreach value: Materialise Colombia S.A.S and 33 Colorado peers

  • Colorado DeviceEstablishmentPulse records like this one: 33
  • Materialise Colombia S.A.S's amount: 77th percentile of 2,570 records
  • Timing: Low: older than 30 days
  • Estimated pipeline if you contact every Colorado peer: $6,600 (peers × rate × deal size; an estimate from your assumptions, not a forecast)

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75 / 100 Score

  • Brings its own devices to market: buys manufacturing, sterilization and QMS help.
  • Class II or III devices: QMS and regulatory demands.
  • Several new listings at once.

What is the DeviceEstablishmentPulse record for Materialise Colombia S.A.S in Medellin Antioquia, Colorado?

Materialise Colombia S.A.S (Medellin Antioquia, CO), a manufacturer, added 3 FDA device listings on 2026-07-08.

How does Materialise Colombia S.A.S compare to other Colorado DeviceEstablishmentPulse records?

Its amount of 3 sits in the upper half (77th percentile) of 2,570 records; the median is 1. It is 120 days old; check the official source for later updates before acting. Its Score of 75/100 puts it among the stronger signals in this feed.

Materialise Colombia S.A.S vs. top 3 peers

OrganizationLocationAmountPercentileRecord date
Materialise Colombia S.A.SMedellin Antioquia, CO377th2026-07-08
Beacon Biosignals, Inc.Boston, MA377th2026-10-16
Endovascular Engineering, Inc.Menlo Park, CA377th2026-10-14
INNO Holdings Inc.Millcreek, UT377th2026-10-05

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From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.

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