FDA.reportPublic FDA data

EARP, 22X50X14 12°

Primary DI
00810161901302
Brand
EARP, 22X50X14 12°
Company
RETROPSOAS TECHNOLOGIES, LLC
Model
EARP2250-1214
Published
2026-10-15
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
true

Product Codes#

Code, Name table
CodeName
MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MAXIntervertebral Fusion Device With Bone Graft, LumbarOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K242457000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242457000EARP Interbody SystemRetropsoas Technologies, LLC2024-10-07MAX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810161901302PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810161901302008101619013028101619013020810161901302

GMDN Terms#

Term, Definition table
TermDefinition
Polymeric spinal interbody fusion cageA device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is in the form of a hollow, porous, threaded and/or fenestrated cylindrical or geometrical device made of non-bioabsorbable synthetic polymer [e.g., polyetheretherketone (PEEK)] that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be included with the device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
119266920
Device count
1
DM exempt
false
Premarket exempt
false
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
00810161900817EARP, 22X40X12 12°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-15
00810161900824EARP, 22X40X14 12°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-15
00810161900831EARP, 22X45X10 6°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-15
00810161900848EARP, 22X45X12 6°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-15
00810161900855EARP, 22X45X14 6°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-15
00810161900862EARP, 22X45X12 12°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-15
00810161900879EARP, 22X45X14 12°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-15
00810161901265EARP, 22X50X10 6°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-15
00810161901272EARP, 22X50X12 6°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-15
00810161901289EARP, 22X50X14 6°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-15
00810161901296EARP, 22X50X12 12°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-15
00810236520001ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520018ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520025ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520032ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520049ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520056ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520063ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520070ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520087ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520094ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520100ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520117ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520124ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520131ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520148ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520155ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520162ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520179ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520186ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10