Abyrx, Inc. (manufacturer, Stamford, CT): 7 new FDA device listings, incl. methyl methacrylate for cranioplasty
Abyrx, Inc. (Stamford, Connecticut): 7 new FDA device listings, incl. methyl methacrylate for cranioplasty. Its amount of 7 is top-decile (90th percentile of 2,709 records). Dated 29 days ago, it is in the active follow-up window. Score 95/100. As of 2026-11-04, 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: 7 · 90th percentile of 2,709 DeviceEstablishmentPulse records · 3.5x the median
Free preview: all 15 published fields of this record are shown below. Locked: 14 related CT DeviceEstablishmentPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Establishment | Abyrx, Inc. |
| Owner / operator | Orthocon, Inc. |
| Role | Manufacturer |
| Establishment types | Manufacture Medical Device; Complaint File Establishment per 21 CFR 820.198 |
| Location | Stamford, CT, US |
| New listings | 7 |
| Devices | Methyl Methacrylate For Cranioplasty; Wax, Bone; Cover, Burr Hole |
| Product codes | GXP, MTJ, GXR |
| Device classes | Class II, Unclassified |
| Medical specialties | Neurology |
| Brand names | Permatage Flowable Settable Bone Paste; Permatage XT Settable Nonabsorbable Hemostatic Bone Putty; Montage XT Cranial Cement; Permatage XT Settable Bone Putty; Permatage Flowable Settable Hemostatic Bone Paste; Montage Flowable Settable Resorbable Bone Paste |
| First new listing | 2026-07-14 |
| Latest new listing | 2026-10-07 |
| FDA registration number | 3005972619 |
| Registration expires | 2027-12-31 |
| amount percentile | 90th of 2,709 (median 2, 3.5x median) |
| Peer records CSV (15 CT 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: 2026-10-07
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
Top DeviceEstablishmentPulse records (CT first): TOMZ Corporation (contract manufacturer, Berlin, CT) · Coopersurgical, Inc. (manufacturer, Trumbull, CT) · Coopersurgical, Inc. (manufacturer, Trumbull, CT) · Linemaster Switch Corp. (contract manufacturer, Woodstock, C · Spine Wave, Inc. (manufacturer, Shelton, CT) · 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, 04 Nov 2026 21:52:36 GMT
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Peer benchmark and outreach value: Abyrx, Inc. and 15 Connecticut peers
- Connecticut DeviceEstablishmentPulse records like this one: 15
- Abyrx, Inc.'s amount: 90th percentile of 2,709 records
- Timing: Medium: dated in the last 30 days
- Estimated pipeline if you contact every Connecticut peer: $3,000 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
95 / 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.
- U.S. establishment.
- Listed in the last 45 days.
What is the DeviceEstablishmentPulse record for Abyrx, Inc. in Stamford, Connecticut?
Abyrx, Inc. (Stamford, CT), a manufacturer, added 7 FDA device listings between 2026-07-14 and 2026-10-07.
How does Abyrx, Inc. compare to other Connecticut DeviceEstablishmentPulse records?
This is a top-decile record: its amount of 7 is 3.5x the median of 2 across 2,709 records. It is 29 days old, still within a typical 45-day follow-up window. Its Score of 95/100 puts it among the stronger signals in this feed.
Abyrx, Inc. vs. top 3 peers
| Organization | Location | Amount | Percentile | Record date |
|---|---|---|---|---|
| Abyrx, Inc. | Stamford, CT | 7 | 90th | 2026-10-07 |
| Inter-Med, Inc. | Racine, WI | 5 | 86th | 2026-10-22 |
| Centerpoint Systems LLC | West Valley City, UT | 5 | 86th | 2026-10-21 |
| GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC | Waukesha, WI | 5 | 86th | 2026-10-19 |
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DeviceEstablishmentPulse: Manufacturer DeviceEstablishmentPulse: U.S. establishment DeviceEstablishmentPulse: records in Connecticut
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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.