Centinel Spine, LLC (specification developer, West Chester, PA): 3 new FDA device listings, incl. manual instruments designed for use with total disc replacement device
Centinel Spine, LLC (West Chester, Pennsylvania): 3 new FDA device listings, incl. manual instruments designed for use with total disc replacement device. Its amount of 3 is above the median of 2 (77th percentile). 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: 3 · 77th percentile of 2,709 DeviceEstablishmentPulse records · 1.5x the median
Free preview: all 14 published fields of this record are shown below. Locked: 46 related PA DeviceEstablishmentPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Establishment | Centinel Spine, 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 | 3 |
| Devices | Manual Instruments Designed For Use With Total Disc Replacement Devices; Bit, Surgical |
| Product codes | QLQ, GFG |
| Device classes | Class I, Class II |
| Medical specialties | Orthopedic, General, Plastic Surgery |
| Brand names | Prodisc C Removal Instruments; prodisc® L Instruments - Hemi chisel; prodisc® L Instruments - Impactors; prodisc c milling bits |
| First new listing | 2026-09-23 |
| Latest new listing | 2026-10-22 |
| FDA registration number | 3007494564 |
| Registration expires | 2027-12-31 |
| amount percentile | 77th of 2,709 (median 2, 1.5x 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: 2026-10-22
- 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: Centinel Spine, LLC and 47 Pennsylvania peers
- Pennsylvania DeviceEstablishmentPulse records like this one: 47
- Centinel Spine, LLC's amount: 77th 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 Centinel Spine, LLC in West Chester, Pennsylvania?
Centinel Spine, LLC (West Chester, PA), a specification developer (outsources manufacturing), added 3 FDA device listings between 2026-09-23 and 2026-10-22.
How does Centinel Spine, LLC compare to other Pennsylvania DeviceEstablishmentPulse records?
Its amount of 3 sits in the upper half (77th percentile) of 2,709 records; the median is 2. 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.
Centinel Spine, LLC vs. top 3 peers
| Organization | Location | Amount | Percentile | Record date |
|---|---|---|---|---|
| Centinel Spine, LLC | West Chester, PA | 3 | 77th | 2026-10-22 |
| TORNIER Inc. | Columbia City, IN | 3 | 77th | 2026-10-21 |
| 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 |
Related records
- Synthes (USA) Products LLC
- TORNIER Inc.
- Deka Research & Development Corp.
- 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.
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.