FDA.reportPublic FDA data

EARP, TRIAL 22X35X14 12°

Primary DI
00810161900336
Brand
EARP, TRIAL 22X35X14 12°
Company
RETROPSOAS TECHNOLOGIES, LLC
Model
EARP-T-2235-1214
Published
2026-10-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810161900336PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810161900336008101619003368101619003360810161900336

GMDN Terms#

Term, Definition table
TermDefinition
Lumbar interspinous decompression instrument set, reusableA collection of surgical instruments and devices intended to be used for the implantation of an interspinous process decompression (IPD) implant that is inserted between two adjacent lumbar spinous processes during a minimally-invasive procedure to decompress neural structures; this is typically to treat a patient suffering from symptomatic degenerative lumbar spinal stenosis (DLSS). It typically consists of a tray, dedicated dilators, a sizing instrument, a spacer (the implant) insertion instrument, implant holders, and a torque-limiting screwdriver. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
119266920
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810161900305EARP, TRIAL 22X35X12 6°EARP-T-2235-06122026-10-16
00810161900312EARP, TRIAL 22X35X14 6°EARP-T-2235-06142026-10-16
00810161900329EARP, TRIAL 22X35X12 12°EARP-T-2235-12122026-10-16
00810161900381EARP, 14X25X08 0°EARP1425-00082026-10-16
00810161900398EARP, 14X25X10 6°EARP1425-06102026-10-16
00810161900404EARP, 14X25X12 6°EARP1425-06122026-10-16
00810161900411EARP, 14X25X12 12°EARP1425-12122026-10-16
00810161900428EARP, 14X30X08 0°EARP1430-00082026-10-16
00810161900435EARP, 14X30X10 6°EARP1430-06102026-10-16
00810161900442EARP, 14X30X12 6°EARP1430-06122026-10-16
00810161900459EARP, 14X30X12 12°EARP1430-12122026-10-16
00810161900466EARP, 14X35X08 0°EARP1435-00082026-10-16
00810161900473EARP, 14X35X10 6°EARP1435-06102026-10-16
00810161900480EARP, 14X35X12 6°EARP1435-06122026-10-16
00810161900497EARP, 14X35X12 12°EARP1435-12122026-10-16
00810161900503EARP, 14X40X10 6°EARP1440-06102026-10-16
00810161900510EARP, 14X40X12 6°EARP1440-06122026-10-16
00810161900527EARP, 14X40X12 12°EARP1440-12122026-10-16
00810161900534EARP, 18X30X08 0°EARP1830-00082026-10-16
00810161900541EARP, 18X30X10 6°EARP1830-06102026-10-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00824846013082Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-10-19
00850078396440SYNQ Single-Use Instrument System(1066)Eca Medical InstrumentsLXH2026-10-19
00889024715295Persona Extended V/V Guide Assembly (MFS)Zimmer, Inc.LXH2026-10-19
08809986489807LnK Spinal Instrument SystemL&K BIOMED CO. ,LTD.LXH2026-10-19
00810111228671Cut GuideTreace Medical Concepts, Inc.LXH2026-10-16
00810161900305EARP, TRIAL 22X35X12 6°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00810161900312EARP, TRIAL 22X35X14 6°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00810161900329EARP, TRIAL 22X35X12 12°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00810161901418EARP TRIAL 22x40x10 6°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00810161901425EARP TRIAL 22x40x12 6°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00810161901432EARP TRIAL 22x40x14 6°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00810161901449EARP TRIAL 22x40x12 12°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00810161901456EARP TRIAL 22x40x14 12°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00810161901463EARP TRIAL 22x45x10 6°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00810161901470EARP TRIAL 22x45x12 6°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00810161901487EARP TRIAL 22x45x14 6°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00810161901494EARP TRIAL 22x45x12 12°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00810161901500EARP TRIAL 22x45x14 12°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00810161901692EARP TRIAL 22x50x10 6°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00810161901708EARP TRIAL 22x50x12 6°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00810161901715EARP TRIAL 22x50x14 6°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00810161901722EARP TRIAL 22x50x12 12°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00810161901739EARP TRIAL 22x50x14 12°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00840606197007MERCURYSPINAL ELEMENTS, INC.LXH2026-10-16
00840606197014MERCURYSPINAL ELEMENTS, INC.LXH2026-10-16
00840606197021MERCURYSPINAL ELEMENTS, INC.LXH2026-10-16
00840606197038MERCURYSPINAL ELEMENTS, INC.LXH2026-10-16
05055662922622Volition™ Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDLXH2026-10-16
00810161900015EARP DISC SPACER INSERTERRETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900022EARP INITIAL INSERTERRETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15