FDA.reportPublic FDA data

EARP, 22X35X12 6°

Primary DI
00810161900749
Brand
EARP, 22X35X12 6°
Company
RETROPSOAS TECHNOLOGIES, LLC
Model
EARP2235-0612
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
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
00810161900749PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810161900749008101619007498101619007490810161900749

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
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
00810161900336EARP, TRIAL 22X35X14 12°EARP-T-2235-12142026-10-16
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810017916139SABER-XA, Anterior Plate, 34Wx11HELEVATION SPINE, INC.MAX2026-10-23
00810017916146SABER-XA, Anterior Plate, 34Wx13HELEVATION SPINE, INC.MAX2026-10-23
00810017916153SABER-XA, Anterior Plate, 34Wx16HELEVATION SPINE, INC.MAX2026-10-23
00810017916207SABER-XA, Anterior Plate, 37Wx11HELEVATION SPINE, INC.MAX2026-10-23
00810017916221SABER-XA, Anterior Plate, 37Wx16HELEVATION SPINE, INC.MAX2026-10-23
00810017916276SABER-XA, Anterior Plate, 40Wx11HELEVATION SPINE, INC.MAX2026-10-23
00810017916283SABER-XA, Anterior Plate, 40Wx13HELEVATION SPINE, INC.MAX2026-10-23
00810017916290SABER-XA, Anterior Plate, 40Wx16HELEVATION SPINE, INC.MAX2026-10-23
00840606176347LucentSPINAL ELEMENTS, INC.MAX2026-10-22
00840606184847LucentSPINAL ELEMENTS, INC.MAX2026-10-22
00840606197106LucentSPINAL ELEMENTS, INC.MAX2026-10-22
B648C29510000Savant Lumbar Interbody Fusion SystemCURITEVA, INC.MAX2026-10-19
M719GLL11403DP Lumbar Interbody SystemGenesys Orthopedics Systems LLCMAX2026-10-19
M719GLL11503DP Lumbar Interbody SystemGenesys Orthopedics Systems LLCMAX2026-10-19
M719GLL11603DP Lumbar Interbody SystemGenesys Orthopedics Systems LLCMAX2026-10-19
00810161900381EARP, 14X25X08 0°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900398EARP, 14X25X10 6°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900404EARP, 14X25X12 6°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900411EARP, 14X25X12 12°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900428EARP, 14X30X08 0°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900435EARP, 14X30X10 6°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900442EARP, 14X30X12 6°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900459EARP, 14X30X12 12°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900466EARP, 14X35X08 0°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
B6785221380Tranquil-L™NEXUS SPINE, L.L.C.MAX2021-12-17
B6785221390Tranquil-L™NEXUS SPINE, L.L.C.MAX2021-12-17
B6785221400Tranquil-L™NEXUS SPINE, L.L.C.MAX2021-12-17
B6785221410Tranquil-L™NEXUS SPINE, L.L.C.MAX2021-12-17
B6785221420Tranquil-L™NEXUS SPINE, L.L.C.MAX2021-12-17
B6785221430Tranquil-L™NEXUS SPINE, L.L.C.MAX2021-12-17