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KIVA Gen 2 Bone Drill

Model ACC5225 · Izi Medical Products, LLC · DI 00815212023644

OCJ — Spinal Channeling Instrument, Vertebroplasty · Class I · 21 CFR 888.4540

UDILibrary device dossier · generated 2026-09-15 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.

Recall history (0)

No recalls linked in the loaded window.

Adverse-event reports — MAUDE (0)

Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.

12232021-01: 0 reports for this device; peer average 1/device2022-07: 0 reports for this device; peer average 1/device2023-01: 0 reports for this device; peer average 1/device2023-04: 0 reports for this device; peer average 1/device2024-01: 0 reports for this device; peer average 1/device2024-04: 0 reports for this device; peer average 1/device2025-01: 0 reports for this device; peer average 1/device2025-04: 0 reports for this device; peer average 1/device2025-07: 0 reports for this device; peer average 1/device2025-09: 0 reports for this device; peer average 3/device2025-10: 0 reports for this device; peer average 1/device2026-01: 0 reports for this device; peer average 1/device2026-04: 0 reports for this device; peer average 1/device2026-05: 0 reports for this device; peer average 1/device0107010401040104070910010405
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2021-0101
2022-0701
2023-0101
2023-0401
2024-0101
2024-0401
2025-0101
2025-0401
2025-0701
2025-0903
2025-1001
2026-0101
2026-0401
2026-0501
This device (reports/month)Average device in OCJ (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K070293 — cited as predicate by K132817

Lineage extracted from public 510(k) summary text (heuristic).

Manufacturer compliance record — Izi Medical Products, LLC

  • VAI 2015-06-04 IZI Medical Products, LLC · 3 citations
  • VAI 2015-06-04 IZI Medical Products, LLC · 3 citations
  • VAI 2013-07-31 IZI Medical Products, LLC · 3 citations
  • VAI 2013-07-31 IZI Medical Products, LLC · 3 citations