FDA.reportPublic FDA data

EARP, IMPLANT LID 22X50

Primary DI
00810161901791
Brand
EARP, IMPLANT LID 22X50
Company
RETROPSOAS TECHNOLOGIES, LLC
Model
EARP-IC_2250-02
Published
2026-10-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
LRPTray, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRPTray, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810161901791PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810161901791008101619017918101619017910810161901791

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
00810161900015EARP DISC SPACER INSERTEREARP-DS-0022026-10-15
00810161900022EARP INITIAL INSERTEREARP-II2026-10-15
00810161900039EARP FINAL INSERTEREARP-FI2026-10-15
00810161900046RETRACTABLE OSTEOTOMEEARP-O2026-10-15
00810161900053EARP BLADE 100EARP-R_001-1002026-10-15
00810161900060EARP BLADE 110EARP-R_001-1102026-10-15
00810161900077EARP BLADE 120EARP-R_001-1202026-10-15
00810161900084EARP BLADE 130EARP-R_001-1302026-10-15
00810161900091EARP BLADE 140EARP-R_001-1402026-10-15
00810161900107EARP BLADE 150EARP-R_001-1502026-10-15
00810161900114EARP BLADE 160EARP-R_001-1602026-10-15
00810161900121EARP BLADE 170EARP-R_001-1702026-10-15
00810161900138EARP BLADE 180EARP-R_001-1802026-10-15
00810161900145EARP BLADE 190EARP-R_001-1902026-10-15
00810161900152EARP CRADLE ASSEMBLYEARP-R_0022026-10-15
00810161900169EARP RETRACTOR CONNECTOREARP-R_0032026-10-15
00810161900176EARP RETRACTOR TILT REPLACEMENTEARP-R_0042026-10-15
00810161900183EARP CUFF TRIAL 3&4MMELEC22102026-10-15
00810161900190EARP CUFF TRIAL 5&6MMELEC22202026-10-15
00810161900206EARP, TRIAL 14X25X08 0°EARP-T-1425-00082026-10-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M697X07300151Xpress Minimally Invasive Pedicle Screw SystemXtant Medical Holdings, Inc.LRP2026-10-14
M697X07300261Xpress Minimally Invasive Pedicle Screw SystemXtant Medical Holdings, Inc.LRP2026-10-14
M697X07300271Xpress Minimally Invasive Pedicle Screw SystemXtant Medical Holdings, Inc.LRP2026-10-14
M697X07300291Xpress Minimally Invasive Pedicle Screw SystemXtant Medical Holdings, Inc.LRP2026-10-14
10198956603554CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-13
10198956612822CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-13
10198956618688CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-13
10198956578487CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-12
10198956580961CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-12
10198956591578CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-12
10198956595576CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-12
10198956604506CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-12
10198956604551CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-12
10198956604568CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-12
10198956605732CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-12
10198956605848CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-12
10198956605855CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-12
10198956606807CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-12
10198956607668CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-12
10198956608351CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-12
10198956608900CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-12
10198956608924CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-12
10198956608931CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-12
10198956608948CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-12
10198956608955CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-12
10198956609341CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-12
10198956610651CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-12
G141588225750Carnegie Surgical LLCCarnegie Surgical LLCLRP2026-10-07
00810017915293Saber-XA, Trial CaddyELEVATION SPINE, INC.LRP2026-10-06
00810017915309SABER-XA, Screw CaddyELEVATION SPINE, INC.LRP2026-10-06