Synthes (USA) Products LLC (specification developer, West Chester, PA): 7 new FDA device listings, incl. plate, cranioplasty, preformed, non-alterable
Synthes (USA) Products LLC (West Chester, Pennsylvania): 7 new FDA device listings, incl. plate, cranioplasty, preformed, non-alterable. Its amount of 7 is top-decile (90th percentile of 2,709 records). Dated 14 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: 46 related PA DeviceEstablishmentPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Establishment | Synthes (USA) Products LLC |
| Owner / operator | SYNTHES (USA) Products 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 | West Chester, PA, US |
| New listings | 7 |
| Devices | Plate, Cranioplasty, Preformed, Non-Alterable; Screw, Fixation, Bone; Plate, Fixation, Bone; Software For Diagnosis/Treatment; Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component |
| Product codes | GXN, HWC, HRS, OSN, KTT |
| Device classes | Class II |
| Medical specialties | Neurology, Orthopedic |
| Brand names | Synthes Patient Specific Implants; TRILEAP Plating System; MAXFRAME AUTOSTRUT with Bluetooth Multi-Axial Correction System; VOLT Ankle Trauma 2.7/3.5 Plating System; VOLT Calcaneus 2.7 Plating System; DePuy Synthes VOLT Medial Distal Femur 3.5 Plating System |
| First new listing | 2026-05-26 |
| Latest new listing | 2026-10-23 |
| FDA registration number | 3008812560 |
| Registration expires | 2027-12-31 |
| amount percentile | 90th of 2,709 (median 2, 3.5x median) |
| Peer records CSV (47 PA 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: 2026-10-23
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
Top DeviceEstablishmentPulse records (PA first): Philips Ultrasound LLC (contract manufacturer, Reedsville, P · Arch Medical Solutions - Philadelphia, LLC Dba Jade Precisio · Globus Medical, Inc. (manufacturer, Audubon, PA) · Alta Smiles, LLC (manufacturer, Fort Washington, PA) · Synthes (USA) Products LLC (specification developer, West Ch · 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: Synthes (USA) Products LLC and 47 Pennsylvania peers
- Pennsylvania DeviceEstablishmentPulse records like this one: 47
- Synthes (USA) Products LLC's amount: 90th percentile of 2,709 records
- Timing: Medium: dated in the last 30 days
- Estimated pipeline if you contact every Pennsylvania peer: $9,400 (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 Synthes (USA) Products LLC in West Chester, Pennsylvania?
Synthes (USA) Products LLC (West Chester, PA), a specification developer (outsources manufacturing), added 7 FDA device listings between 2026-05-26 and 2026-10-23.
How does Synthes (USA) Products LLC compare to other Pennsylvania 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 fresh: dated 14 days ago, inside the window where early outreach matters most. Its Score of 95/100 puts it among the stronger signals in this feed.
Synthes (USA) Products LLC vs. top 3 peers
| Organization | Location | Amount | Percentile | Record date |
|---|---|---|---|---|
| Synthes (USA) Products LLC | West Chester, PA | 7 | 90th | 2026-10-23 |
| SHOULDER INNOVATIONS, Inc | Grand Rapids, MI | 7 | 90th | 2026-10-15 |
| Sol-Millennium Medical, Inc. | Chicago, IL | 8 | 90th | 2026-09-28 |
| Deka Research & Development Corp. | Manchester, NH | 5 | 86th | 2026-10-19 |
Related records
DeviceEstablishmentPulse: Specification developer (outsources manufacturing) DeviceEstablishmentPulse: U.S. establishment DeviceEstablishmentPulse: records in Pennsylvania
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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.