# K253118: Companion Spine DIAM™ Instrumentation

- Pathway: 510(k) (Traditional)
- Applicant: Companion Spine France
- Decided: Dec 16, 2025 after 83 days
- Product code: QLR (Manual Instruments Designed For Use With Non-Fusion Spinous Process Spacer Devices)
- Device class: 2
- Regulation: 21 CFR 888.4520
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K200824: Cardinal Health SMARTGOWN Breathable Surgical Gown, Cardinal Health SMARTGOWN AIR Breathable Surgical Gown, Cardinal Health200, LLC (2020). Our OCR of the scanned summary read K200824, FDA’s number for Cardinal Health SMARTGOWN Breathable Surgical Gown… (Cardinal Health200, LLC). Its FDA name has none of the distinctive words the summary uses for the device it names, “coflex Interlaminar Technology Instrumentation”. Kept off the family tree. Summary page 5.

## Most influential descendants
- K253374: LimiFlex® Dynamic Sagittal Tether Instrument Set (2026), 0 descendants of its own

## Indications for use
The Companion Spine DIAM ™ Instrumentation is indicated for the insertion and positioning of the Companion Spine DIAM ™ Spinal Stabilization System devices, or if required, removal of the implantable device.

Source page: https://510kreport.com/device/K253118
Methodology: https://510kreport.com/methodology