510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K131427Substantially Equivalent

Lotus

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

K131427 is the FDA 510(k) clearance record for LOTUS, a class II device, cleared for Spinal Elements, Inc. on under FDA product code KWP (Appliance, Fixation, Spinal Interlaminal). FDA records list 66 510(k) clearances for Spinal Elements, Inc., from to . As of , FDA records show no recalls naming K131427.

Clearance record

Decision date
Received
(160 days to decision)
Product code
KWP Appliance, Fixation, Spinal Interlaminal
Regulation
21 CFR 888.3050
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 KWP

Trailing 12 months

FDA records hold no clearances under product code KWP in the trailing twelve months.

FDA records show no clearances under product code KWP in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KWP, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260