510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K201029Substantially Equivalent

Sapphire® Spinal System, Sapphire X Anterior Cervical Plate Spinal System

Spinal Elements, Inc, Carlsbad CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K201029 is the FDA 510(k) clearance record for Sapphire® Spinal System, Sapphire X Anterior Cervical Plate Spinal System, a class II device, cleared for Spinal Elements, Inc. on under FDA product code KWQ (Appliance, Fixation, Spinal Intervertebral Body). FDA records list 66 510(k) clearances for Spinal Elements, Inc., from to . As of , FDA records show no recalls naming K201029.

Clearance record

Decision date
Received
(58 days to decision)
Product code
KWQ Appliance, Fixation, Spinal Intervertebral Body
Regulation
21 CFR 888.3060
Device class
Class II
Review panel
Orthopedic
Applicant
Spinal Elements, Inc. 3115 Melrose Dr. Suite 200, Carlsbad CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KWQ

Trailing 12 months
11 clearances under product code KWQ in the twelve months to October 2026, March 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code KWQ, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20262
March 20263
April 20261
May 20262
June 20260
July 20261
August 20260
September 20261
October 20260