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"Osteotome 1/4"""

Model PI-0709 · CAPTIVA SPINE, INC. · DI M739PI0709

GFI — Osteotome, Manual · Class I · 21 CFR 878.4800

UDILibrary device dossier · generated 2026-09-10 · 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.

11222020-06: 0 reports for this device; peer average 2/device2025-10: 0 reports for this device; peer average 2/device2026-06: 0 reports for this device; peer average 1/device061006
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2020-0602
2025-1002
2026-0601
This device (reports/month)Average device in GFI (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — CAPTIVA SPINE, INC.

  • NAI 2025-01-14 Captiva Spine, Inc · 0 citations
  • NAI 2025-01-14 Captiva Spine, Inc · 0 citations
  • VAI 2017-02-17 Captiva Spine, Inc · 3 citations
  • VAI 2017-02-17 Captiva Spine, Inc · 3 citations
  • VAI 2013-01-16 Captiva Spine, Inc · 2 citations
  • VAI 2013-01-16 Captiva Spine, Inc · 2 citations
  • VAI 2012-03-09 Captiva Spine, Inc · 8 citations
  • VAI 2012-03-09 Captiva Spine, Inc · 8 citations