510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K253374Substantially Equivalent

LimiFlex® Dynamic Sagittal Tether Instrument Set

Empirical Spine, Inc., Morgan Hill CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K253374 is the FDA 510(k) clearance record for LimiFlex® Dynamic Sagittal Tether Instrument Set, a class II device, cleared for Empirical Spine on under FDA product code SGL (Manual Instruments Designed For Use With Non-Fusion Spinous Process Tension Band Implant). FDA's definition for product code SGL reads: "The devices are intended to manipulate tissue or implant materials for the positioning, alignment, placement, or removal of spinous process tension band implant for non-fusion use". FDA records list one 510(k) clearance for Empirical Spine. As of , FDA records show no recalls naming K253374.

Clearance record

Decision date
Received
(259 days to decision)
Product code
SGL Manual Instruments Designed For Use With Non-Fusion Spinous Process Tension Band Implant
Regulation
21 CFR 888.4520
Device class
Class II
Review panel
Orthopedic
Applicant
Empirical Spine 18655 Madrone Pkwy., Suite 180, Morgan Hill CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code SGL

Trailing 12 months
1 clearance under product code SGL in the twelve months to October 2026, June 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code SGL, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20260
September 20260
October 20260