Spine Wave, Inc. (manufacturer, Shelton, CT): 6 new FDA device listings, incl. bit, drill
Spine Wave, Inc. (Shelton, Connecticut): 6 new FDA device listings, incl. bit, drill. Its amount of 6 is above the median of 1 (88th percentile). Dated 66 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: 6 · 88th percentile of 2,570 DeviceEstablishmentPulse records · 6.0x the median
Free preview: all 14 published fields of this record are shown below. Locked: 13 related CT DeviceEstablishmentPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Establishment | Spine Wave, Inc. |
| Role | Manufacturer |
| Establishment types | Manufacture Medical Device |
| Location | Shelton, CT, US |
| New listings | 6 |
| Devices | Bit, Drill; Gauge, Depth; Guide, Surgical, Instrument; Intervertebral Fusion Device With Bone Graft, Lumbar; Bone Cement, Posterior Screw Augmentation; Thoracolumbosacral Pedicle Screw System |
| Product codes | HTW, HTJ, FZX, MAX, PML, NKB |
| Device classes | Class I, Class II |
| Medical specialties | Orthopedic, General, Plastic Surgery |
| Brand names | Drill; Depth Gauge; Drill Guide; Exceed® Plus Biplanar Expandable Interbody System; Salvo® Spine System |
| First new listing | 2026-07-20 |
| Latest new listing | 2026-08-31 |
| FDA registration number | 3004638600 |
| Registration expires | 2026-12-31 |
| amount percentile | 88th of 2,570 (median 1, 6.0x median) |
| Peer records CSV (14 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: 2026-08-31
- Data refreshed: 2026-10-28
- Refunds on request within 14 days
Top DeviceEstablishmentPulse records (CT first): TOMZ Corporation (contract manufacturer, Berlin, CT) · Coopersurgical, Inc. (manufacturer, Trumbull, CT) · Abyrx, Inc. (manufacturer, Stamford, CT) · Linemaster Switch Corp. (contract manufacturer, Woodstock, C · Trumedx LLC (other, 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, 28 Oct 2026 20:51:27 GMT
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Peer benchmark and outreach value: Spine Wave, Inc. and 14 Connecticut peers
- Connecticut DeviceEstablishmentPulse records like this one: 14
- Spine Wave, Inc.'s amount: 88th percentile of 2,570 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Connecticut peer: $2,800 (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 Spine Wave, Inc. in Shelton, Connecticut?
Spine Wave, Inc. (Shelton, CT), a manufacturer, added 6 FDA device listings between 2026-07-20 and 2026-08-31.
How does Spine Wave, Inc. compare to other Connecticut DeviceEstablishmentPulse records?
Its amount of 6 sits in the upper half (88th percentile) of 2,570 records; the median is 1. It is 66 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.
Spine Wave, Inc. vs. top 3 peers
| Organization | Location | Amount | Percentile | Record date | Compare |
|---|---|---|---|---|---|
| Spine Wave, Inc. | Shelton, CT | 6 | 88th | 2026-08-31 | This record |
| Boston Scientific Corp., Marina Bay Cust. Fulfillment Center | Quincy, MA | 6 | 88th | 2026-10-16 | View record → |
| Inquis Medical, Inc. | Menlo Park, CA | 5 | 87th | 2026-10-16 | View record → |
| Abyrx, Inc. | Stamford, CT | 7 | 90th | 2026-10-07 | Compare Spine Wave, Inc. vs Abyrx, Inc. → |
Related records
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.