Where does the data come from?

openFDA device registration and listing endpoint (U.S. Food and Drug Administration). Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm

AVALIGN TECHNOLOGIES, Inc. (specification developer, Fort Wayne, IN): 2 new FDA device listings, incl. intervertebral fusion device with bone graft, cervical

Q: How to monitor AVALIGN TECHNOLOGIES, Inc. and peer specification developer (outsources manufacturing) records

DeviceEstablishmentPulse lists new DeviceEstablishmentPulse records from openFDA device registration and listing endpoint (U.S. Food and Drug Administration) as they are published; a free weekly email digest and paid alerts follow Indiana records like this one.

AVALIGN TECHNOLOGIES, Inc. (Fort Wayne, Indiana): 2 new FDA device listings, incl. intervertebral fusion device with bone graft, cervical. Its amount of 2 is above the median of 1 (69th percentile). Dated 128 days ago, it serves as a historical benchmark. Score 70/100. As of 2026-10-28, from openFDA device registration and listing endpoint (U.S. Food and Drug Administration).

Data as of 2026-10-28 · Compiled by Zalwin from openFDA device registration and listing endpoint (U.S. Food and Drug Administration)

amount: 2 · 69th percentile of 2,570 DeviceEstablishmentPulse records · 2.0x the median

Free preview: all 14 published fields of this record are shown below. Locked: 72 related IN DeviceEstablishmentPulse records and the 5-column CSV export.

Field	Value
Establishment	AVALIGN TECHNOLOGIES, Inc.
Owner / operator	Avalign Technologies
Role	Specification developer (outsources manufacturing)
Establishment types	Develop Specifications But Do Not Manufacture At This Facility
Location	Fort Wayne, IN, US
New listings	2
Devices	Intervertebral Fusion Device With Bone Graft, Cervical; Intervertebral Fusion Device With Integrated Fixation, Cervical
Product codes	ODP, OVE
Device classes	Class II
Medical specialties	Orthopedic
First new listing	2026-06-29
Latest new listing	2026-06-29
FDA registration number	3008864603
Registration expires	2027-12-31
amount percentile	69th of 2,570 (median 1, 2.0x median)
Peer records CSV (73 IN records)	🔒 Click to unlock →
CRM-ready export with official source URLs	🔒 Click to unlock →

View the official record

Markdown version

Watch AVALIGN TECHNOLOGIES, Inc.

Free email alert. Alert me when this company gets a new filing, lien, permit, contract or expiry in this feed. One confirmation email; unsubscribe any time.

Free for 1 company. More companies from $9/mo (25), $49/mo (500 + CSV), $199/mo (500 + CSV + API). Cancel any time from the link in every email.

Free first: a 10-record sample of IN records

See the real columns before you buy. One confirmation email, nothing else unless you opt in.

Unlock AVALIGN TECHNOLOGIES + all 73 IN records (CSV)

Instant CSV download · Card, Apple Pay, Google Pay or Link via Stripe · No account required
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: 2026-06-29
Data refreshed: 2026-10-28
Refunds on request within 14 days

Search all IN records free →

Top DeviceEstablishmentPulse records (IN first): Laparomed Private Limited (manufacturer, Mumbai Maharashtra, · Lords Mark Industries Ltd. (manufacturer, Daman and Diu Dadr · Micropulse Inc (contract manufacturer, Columbia City, IN) · Zimmer, Inc. (contract manufacturer, Warsaw, IN) · Apothecaries Sundries Mfg Pvt Ltd (manufacturer, GURUGRAM Ha · 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

Is this your business? Add a "Listed on Zalwin" badge to your site

Paste this snippet into your website. It links to this public record; nothing is tracked on your site.

<a href="https://zalwin.com/report/deviceestablishmentpulse/avalign-technologies-inc-fort-wayne-in--fdaest-3008864603-2026-06-29" rel="noopener"><img src="https://zalwin.com/badge/listed.svg" alt="AVALIGN TECHNOLOGIES, Inc. on Zalwin public records" width="150" height="28"></a>

Peer benchmark and outreach value: AVALIGN TECHNOLOGIES, Inc. and 73 Indiana peers

Your role Typical deal size (USD) Assumed reply-to-deal rate (%)

Indiana DeviceEstablishmentPulse records like this one: 73
AVALIGN TECHNOLOGIES, Inc.'s amount: 69th percentile of 2,570 records
Timing: Low: older than 30 days
Estimated pipeline if you contact every Indiana peer: $14,600 (peers × rate × deal size; an estimate from your assumptions, not a forecast)

70 / 100 Score

Brings its own devices to market: buys manufacturing, sterilization and QMS help.
Class II or III devices: QMS and regulatory demands.
U.S. establishment.

What is the DeviceEstablishmentPulse record for AVALIGN TECHNOLOGIES, Inc. in Fort Wayne, Indiana?

AVALIGN TECHNOLOGIES, Inc. (Fort Wayne, IN), a specification developer (outsources manufacturing), added 2 FDA device listings on 2026-06-29.

How does AVALIGN TECHNOLOGIES, Inc. compare to other Indiana DeviceEstablishmentPulse records?

Its amount of 2 sits in the upper half (69th percentile) of 2,570 records; the median is 1. It is 128 days old; check the official source for later updates before acting. Its Score of 70/100 puts it among the stronger signals in this feed.

AVALIGN TECHNOLOGIES, Inc. vs. top 3 peers

Organization	Location	Amount	Percentile	Record date
AVALIGN TECHNOLOGIES, Inc.	Fort Wayne, IN	2	69th	2026-06-29
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

More Indiana public-record feeds

SEC 8-K Corporate Trigger Events in Indiana New, Terminating & Large 401(k) Plans from Form 5500 Filings in Indiana Industrial Environmental Noncompliance Radar in Indiana Carrier Out-of-Service Alerts in Indiana Federal Alcohol Permit Holder Directory in Indiana EPA Brownfields Award Tracker in Indiana New Health-Based Drinking Water Violations by Water System (EPA SDWIS) in Indiana Largest U.S. Greenhouse Gas Emitters by Company, Sector & State (EPA GHGRP) in Indiana

How to monitor AVALIGN TECHNOLOGIES, Inc. and peer specification developer (outsources manufacturing) records

Get new DeviceEstablishmentPulse records like AVALIGN TECHNOLOGIES, Inc. by email (free, weekly)

We email one confirmation link now; the weekly digest starts only after you confirm. One-click unsubscribe in every email.

Double opt-in: nothing is sent until you click the confirmation link. One-click unsubscribe.

See this week's digest

Get new device listings in your specialties

DeviceEstablishmentPulse emails device establishments with new FDA listings matching your roles and states.

See plans

✓ Read-only, live public data · Key and unlock right after payment · Card, Apple Pay, Google Pay or Link via Stripe · Refunds on request within 14 days

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.