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

Manual Instruments Designed For Use With Non-Fusion Spinous Process Tension Band Implant

21 CFR 888.4520 / Orthopedic
FDA source (opens on fda.gov)

SGL is the FDA product code for Manual Instruments Designed For Use With Non-Fusion Spinous Process Tension Band Implant, a class II device type, regulated under 21 CFR 888.4520. FDA's definition for this code 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". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
SGL
Device name
Manual Instruments Designed For Use With Non-Fusion Spinous Process Tension Band Implant
FDA definition
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.
Regulation
21 CFR 888.4520
Device class
Class II
Review panel
Orthopedic
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code SGL

By decision year
1 clearance under product code SGL with a decision year between 2026 and 2026, 2026 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code SGL by decision year
YearClearances
20261

Applicants with the most clearances

Product code SGL
Applicants holding the most 510(k) clearances under product code SGL
ApplicantClearances
Empirical Spine, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code