Baby Gorilla/Gorilla Plating System— 510(k) K221465

Name: FDA 510(k) clearance K221465
Creator: U.S. Food and Drug Administration
Published: 2022-06-17

Substantially Equivalent

Paragon 28, Inc.

FDA 510(k) clearance K221465 for Baby Gorilla/Gorilla Plating System, Substantially Equivalent on 2022-06-17. Applicant: Paragon 28, Inc.. Device class: 2.

Clearance details

Applicant: Paragon 28, Inc.
Product code: Code HRS
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2022-05-19
Decision date: 2022-06-17
Decision: Substantially Equivalent
Clearance type: Special
Location: Englewood, CO, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HRS

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K261647 — Tempo Plating System; Ultra Compression Screw System2026-09-03
K261830 — FRAXION 3.5 Plate System (Various - See Catalog) +3 more2026-08-28
K262537 — Versalock Sterile Plating System2026-08-19
K260277 — MIKRON TRAUMA BONE PLATE& SCREW SYSTEM2026-08-13
K261511 — Xpert Ankle2026-07-28

More clearances from Paragon 28, Inc.

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K262722 — Primal K-Wire (P99-193-1410)2026-08-28
K261121 — Megalodon Dynamic Compression System2026-08-06
K262047 — Grappler Suture Anchor System2026-08-03
K253886 — Grappler Suture Anchor PCFD Tether System2026-03-17
K253591 — Phantom® Hindfoot TTC/TC Nail System2026-03-05

Adverse events under product code HRS

product code HRS

Death: 27
Injury: 10,340
Malfunction: 3,328
Total: 13,695

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.