DeviceEstablishmentPulse / report
Elemental Orthopedics LLC (specification developer, Marcola, OR): 1 new FDA device listing, incl. component, cast
Elemental Orthopedics LLC (Marcola, Oregon): 1 new FDA device listing, incl. component, cast. Its amount of 1 is above the median of 1 (50th percentile). Dated 173 days ago, it serves as a historical benchmark. Score 55/100. 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: 1 · 50th percentile of 2,570 DeviceEstablishmentPulse records · 1.0x the median
Free preview: all 14 published fields of this record are shown below. Locked: 8 related OR DeviceEstablishmentPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Establishment | Elemental Orthopedics LLC |
| Role | Specification developer (outsources manufacturing) |
| Establishment types | Complaint File Establishment per 21 CFR 820.198; Develop Specifications But Do Not Manufacture At This Facility |
| Location | Marcola, OR, US |
| New listings | 1 |
| Devices | Component, Cast |
| Product codes | LGF |
| Device classes | Class I |
| Medical specialties | Orthopedic |
| Brand names | Healthy Cast Ventilator |
| First new listing | 2026-05-15 |
| Latest new listing | 2026-05-15 |
| FDA registration number | 3045953406 |
| Registration expires | 2026-12-31 |
| amount percentile | 50th of 2,570 (median 1, 1.0x median) |
| Peer records CSV (9 OR records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 Click to unlock → |
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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: 2026-05-15
- Data refreshed: 2026-10-28
- Refunds on request within 14 days
Top DeviceEstablishmentPulse records (OR first): Ortho-Med, Inc. (repackager or relabeler, Tigard, OR) · Orchid Orthopedic Solutions Oregon, Inc. (contract manufactu · Titanlinks Logistics LLC (repackager or relabeler, Newark, D · Millstone Medical Outsourcing LLC (contract manufacturer, Ol · Soher Med Limited (foreign exporter, Hong Kong, HK) · Browse all by state and category →
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: Elemental Orthopedics LLC and 9 Oregon peers
- Oregon DeviceEstablishmentPulse records like this one: 9
- Elemental Orthopedics LLC's amount: 50th percentile of 2,570 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Oregon peer: $1,800 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
55 / 100 Score
- Brings its own devices to market: buys manufacturing, sterilization and QMS help.
- U.S. establishment.
What is the DeviceEstablishmentPulse record for Elemental Orthopedics LLC in Marcola, Oregon?
Elemental Orthopedics LLC (Marcola, OR), a specification developer (outsources manufacturing), added 1 FDA device listing on 2026-05-15.
How does Elemental Orthopedics LLC compare to other Oregon DeviceEstablishmentPulse records?
Its amount of 1 sits in the upper half (50th percentile) of 2,570 records; the median is 1. It is 173 days old; check the official source for later updates before acting.
Elemental Orthopedics LLC vs. top 3 peers
| Organization | Location | Amount | Percentile | Record date |
|---|---|---|---|---|
| Elemental Orthopedics LLC | Marcola, OR | 1 | 50th | 2026-05-15 |
| Davol Inc., Sub. C.R. Bard, Inc. | Warwick, RI | 3 | 77th | 2026-10-14 |
| Ge Medical Systems, LLC | Waukesha, WI | 3 | 77th | 2026-10-06 |
| Align Technology, Inc. | San Jose, CA | 3 | 77th | 2026-09-30 |
Related records
- Alc Enterprises Inc
- Boston Scientific Corporation
- SHOULDER INNOVATIONS, Inc
- Davol Inc., Sub. C.R. Bard, Inc.
- MEDLINE INDUSTRIES, LP - Northfield
- Ge Medical Systems, LLC
- Align Technology, Inc.
- Orthopediatrics, Corp
- Sol-Millennium Medical, Inc.
- Wright Medical Technology, Inc.
- Arthrex, Inc.
- Deka Research & Development Corp.
DeviceEstablishmentPulse: Specification developer (outsources manufacturing) DeviceEstablishmentPulse: U.S. establishment DeviceEstablishmentPulse: records in Oregon
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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.