DeviceEstablishmentPulse / report
Synthes (USA) Products LLC (specification developer, West Chester, PA): 5 new FDA device listings, incl. plate, cranioplasty, preformed, non-alterable
Synthes (USA) Products LLC (West Chester, Pennsylvania): 5 new FDA device listings, incl. plate, cranioplasty, preformed, non-alterable. Its amount of 5 is above the median of 1 (87th percentile). Dated 140 days ago, it serves as a historical benchmark. Score 85/100. 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: 5 · 87th percentile of 2,570 DeviceEstablishmentPulse records · 5.0x the median
Free preview: all 15 published fields of this record are shown below. Locked: 43 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 | 5 |
| Devices | Plate, Cranioplasty, Preformed, Non-Alterable; Software For Diagnosis/Treatment; Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component; Plate, Fixation, Bone |
| Product codes | GXN, OSN, KTT, HRS |
| Device classes | Class II |
| Medical specialties | Neurology, Orthopedic |
| Brand names | Synthes Patient Specific Implants; 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 | 2026-06-17 |
| FDA registration number | 3008812560 |
| Registration expires | 2027-12-31 |
| amount percentile | 87th of 2,570 (median 1, 5.0x median) |
| Peer records CSV (44 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: 2026-06-17
- Data refreshed: 2026-10-28
- Refunds on request within 14 days
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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: Synthes (USA) Products LLC and 44 Pennsylvania peers
- Pennsylvania DeviceEstablishmentPulse records like this one: 44
- Synthes (USA) Products LLC's amount: 87th percentile of 2,570 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Pennsylvania peer: $8,800 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
85 / 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.
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 5 FDA device listings between 2026-05-26 and 2026-06-17.
How does Synthes (USA) Products LLC compare to other Pennsylvania DeviceEstablishmentPulse records?
Its amount of 5 sits in the upper half (87th percentile) of 2,570 records; the median is 1. It is 140 days old; check the official source for later updates before acting. Its Score of 85/100 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 | 5 | 87th | 2026-06-17 |
| Orthopediatrics, Corp | Warsaw, IN | 5 | 87th | 2026-09-28 |
| Wright Medical Technology, Inc. | Arlington, TN | 5 | 87th | 2026-09-28 |
| Alc Enterprises Inc | Brooklyn, NY | 4 | 83rd | 2026-10-18 |
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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.