510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K253118Substantially Equivalent

Companion Spine DIAM™ Instrumentation

Companion Spine France, Mérignac, FR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K253118 is the FDA 510(k) clearance record for Companion Spine DIAM™ Instrumentation, a class II device, cleared for Companion Spine France on under FDA product code QLR (Manual Instruments Designed For Use With Non-Fusion Spinous Process Spacer Devices). FDA's definition for product code QLR reads: "The devices are intended to manipulate tissue or implant materials for the positioning, alignment, placement, or removal of spinous process spacer devices for non-fusion use". FDA records list one 510(k) clearance for Companion Spine France. As of , FDA records show no recalls naming K253118.

Clearance record

Decision date
Received
(83 days to decision)
Product code
QLR Manual Instruments Designed For Use With Non-Fusion Spinous Process Spacer Devices
Regulation
21 CFR 888.4520
Device class
Class II
Review panel
Orthopedic
Applicant
Companion Spine France 5 Allée Des Acacias, Mérignac, FR
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QLR

Trailing 12 months
1 clearance under product code QLR in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code QLR, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260