510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K101848Substantially Equivalent

Sapphire Anterior Cervical Plate System

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

K101848 is the FDA 510(k) clearance record for SAPPHIRE ANTERIOR CERVICAL PLATE 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 K101848.

Clearance record

Decision date
Received
(105 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. 2744 Loker Ave. W. Suite 100, 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 November 2026, March 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code KWQ, trailing twelve months
MonthClearances
December 20251
January 20260
February 20262
March 20263
April 20261
May 20262
June 20260
July 20261
August 20260
September 20261
October 20260
November 20260