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Sign in to claim this brandParagon 28
US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 14445 Grasslands Dr., Englewood, CO, 80112
- Website
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- —
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- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 3008650117
- DUNS Number
- —
Catalogue (5858)
Page 118 of 118| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Baby Gorilla/Gorilla Plating System | K190365 | FDA 510(k) | Class II | Active |
| Monkey RingsTM External Fixation System | K232838 | FDA 510(k) | Class II | Active |
| Baby Gorilla/Gorilla Plating System | K221465 | FDA 510(k) | Class II | Active |
| Grappler Suture Anchor System | K231867 | FDA 510(k) | Class II | Active |
| Baby Gorilla®/Gorilla® Plating System | K250952 | FDA 510(k) | Class II | Active |
| HammerToe Compression System | K183228 | FDA 510(k) | Class II | Active |
| Monkey Rings External Ring Fixation System | K253613 | FDA 510(k) | Class II | Active |
| Monster BITE Screw System | K153378 | FDA 510(k) | Class II | Active |
Related Companies
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FDA Recalls (2)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Sep 28, 2018 | Z-0662-2020 | — | terminated | It has been determined that the wedge implant kit is permanently mislabeled with the wrong size. The wedge implant is a 10mm size and is permanently marked as a 12mm size. Use of the product could result in improper preparation of the surgical site causing delays in surgery. |
| Dec 19, 2017 | Z-2261-2018 | — | terminated | Missing drill guide as stated in the package. |