510(k) Report

FDA applicant

Integrity Spine

San Antonio, TX2 decisions2013–20230 recalls

FDA records 2 decisions for Integrity Spine (San Antonio, TX) from 2013 to 2023: 2 510(k) clearances. All are in product code ODP (Intervertebral Fusion Device With Bone Graft…). Its devices cite 7 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, orthopedic panel, where it files most

How often FDA has decided Integrity Spine’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2013: 12023: 1
2013high 1 (2013) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2013.

FIG. 1 — Integrity Spine by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • ODPIntervertebral Fusion Device With Bone Graft, Cervical2decisions

Whose devices does it build on?

Its devices cite 7 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K132718Integrity Spine Core SystemIntegrity Spine · 20131cites it

What has FDA decided for it lately?

  • K223043The Integrity Spine Core SystemIntegrity Spine · 2023
  • K132718Integrity Spine Core SystemIntegrity Spine · 2013

All 2 as Integrity Spine →

Other applicant names beginning “Integrity”

FDA records each applicant name separately; these may or may not be the same firm.

Integrity Implants, Inc. 11Integrity Optics, Inc. 2Integrity Practice Management, Inc. 1Integrity Life Sciences 1Integrity Medical Software, Inc. 1Integrity Spine Lumbar Interbody Fusion System 1Integrity Implants Inc. Dba Accelus 1Integrity Orthopaedics, Inc. 1