Paragon 28 (manufacturer, Englewood, CO): 9 new FDA device listings, incl. kit, surgical instrument, disposable
Paragon 28 (Englewood, Colorado): 9 new FDA device listings, incl. kit, surgical instrument, disposable. Its amount of 9 is top-decile (92nd percentile of 2,570 records). Dated 27 days ago, it is in the active follow-up window. Score 95/100. 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: 9 · 92th percentile of 2,570 DeviceEstablishmentPulse records · 9.0x the median
Free preview: all 14 published fields of this record are shown below. Locked: 32 related CO DeviceEstablishmentPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Establishment | Paragon 28 |
| Role | Manufacturer |
| Establishment types | Complaint File Establishment per 21 CFR 820.198; Develop Specifications But Do Not Manufacture At This Facility; Manufacture Medical Device; Repack or Relabel Medical Device |
| Location | Englewood, CO, US |
| New listings | 9 |
| Devices | Kit, Surgical Instrument, Disposable; Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer; Fastener, Fixation, Nondegradable, Soft Tissue; Staple, Fixation, Bone; Filler, Bone Void, Osteoinduction (W/O Human Growth Factor); Filler, Bone Void, Calcium Compound; Plate, Fixation, Bone; Screw, Fixation, Bone |
| Product codes | KDD, HSN, MBI, JDR, MBP, MQV, HRS, HWC |
| Device classes | Class I, Class II |
| Medical specialties | General, Plastic Surgery, Orthopedic |
| Brand names | Primal OCD; APEX 3D Total Ankle Replacement System, APEX 3D S Diamond Tibia; Grappler Suture Anchor System; Megalodon Dynamic Compression System; JAWS Nitinol Staple System; BEAST Injectable Putty; DAC Dynamic Active Compression Plate |
| First new listing | 2026-05-12 |
| Latest new listing | 2026-10-08 |
| FDA registration number | 3008650117 |
| Registration expires | 2027-12-31 |
| amount percentile | 92th of 2,570 (median 1, 9.0x median) |
| Peer records CSV (33 CO 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: 2026-10-08
- Data refreshed: 2026-10-28
- Refunds on request within 14 days
Top DeviceEstablishmentPulse records (CO first): Simple Style Inc (specification developer, Brighton, CO) · Terumo BCT STERILIZATION SERVICES, Inc. (contract sterilizer · Altivera Medical, Inc. (repackager or relabeler, Englewood, · Covidien (specification developer, Lafayette, CO) · LivaNova USA, INC. (contract manufacturer, Arvada, CO) · 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: Paragon 28 and 33 Colorado peers
- Colorado DeviceEstablishmentPulse records like this one: 33
- Paragon 28's amount: 92nd percentile of 2,570 records
- Timing: Medium: dated in the last 30 days
- Estimated pipeline if you contact every Colorado peer: $6,600 (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 Paragon 28 in Englewood, Colorado?
Paragon 28 (Englewood, CO), a manufacturer, added 9 FDA device listings between 2026-05-12 and 2026-10-08.
How does Paragon 28 compare to other Colorado DeviceEstablishmentPulse records?
This is a top-decile record: its amount of 9 is 9.0x the median of 1 across 2,570 records. It is 27 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.
Paragon 28 vs. top 3 peers
| Organization | Location | Amount | Percentile | Record date |
|---|---|---|---|---|
| Paragon 28 | Englewood, CO | 9 | 92nd | 2026-10-08 |
| Boston Scientific Corporation | Coventry, RI | 10 | 93rd | 2026-10-16 |
| Abyrx, Inc. | Stamford, CT | 7 | 90th | 2026-10-07 |
| Boston Scientific Corp., Marina Bay Cust. Fulfillment Center | Quincy, MA | 6 | 88th | 2026-10-16 |
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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.