Chrysalis Intelligence · Sponsors · Companion Spine France

Companion Spine France

Mérignac, FR · 1 510(k) clearances · 4 PMAs

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Total clearances

1

2025-12-16 → 2025-12-16

Last 12 months

1

Product codes

1

Most recent

2025-12-16

Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code	Device name	Class	Specialty	Clearances	Most recent
QLR	Manual Instruments Designed For Use With Non-Fusion Spinous Process Spacer Devices	Class II	Orthopedic	1	2025-12-16

Class III

PMA approvals (4)

Total PMA records

4

Originals + supplements

Distinct product codes

1

First decision

2020-04-07

Most recent

2026-05-22

Date	PMA #	Trade name	Type	Code	Device name	Specialty
2026-05-22	P110008-S015	coflex® Interlaminar Technology	Normal 180 Day Track No User Fee	NQO	Prosthesis, Spinous Process Spacer/Plate	Unknown
2021-03-31	P110008-S013	coflex Interlaminar Stabilization Device	Normal 180 Day Track No User Fee	NQO	Prosthesis, Spinous Process Spacer/Plate	Unknown
2020-08-05	P110008-S012	coflex® Interlaminar Technology	Special (Immediate Track)	NQO	Prosthesis, Spinous Process Spacer/Plate	Unknown
2020-04-07	P110008-S011	coflex Interlaminar Stabilization Device	Normal 180 Day Track No User Fee	NQO	Prosthesis, Spinous Process Spacer/Plate	Unknown

Filings

All 510(k) clearances (1)

Date	K-number	Device	Code	Class	Specialty
2025-12-16	K253118	Companion Spine DIAM Instrumentation	QLR	Class II	Orthopedic