FDA.reportPublic FDA data

RODIN Expandable Lumbar Cage System

Primary DI
00841732140622
Brand
RODIN Expandable Lumbar Cage System
Company
CTL Medical Corporation
Model
027.7320
Device description
RODIN Trial, 6°, W27xL21,H10mm
Published
2024-05-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
MAXIntervertebral Fusion Device With Bone Graft, Lumbar
MQPSpinal vertebral body replacement device

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MAXIntervertebral Fusion Device With Bone Graft, LumbarOrthopedic2
MQPSpinal Vertebral Body Replacement DeviceOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841732140622PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841732140622008417321406228417321406220841732140622

GMDN Terms#

Term, Definition table
TermDefinition
General internal orthopaedic fixation system implantation kitA collection of instruments and devices intended to be used for the placement of an internal orthopaedic fixation system into or onto all types of bones (e.g., bones of limbs, spine, pelvis, or craniomaxillofacial). It is a non-dedicated device that includes various metallic and/or plastic reusable devices [e.g., retractors, rods, clamps, drills, pins, saws, screwdrivers, guides, trials, impactors] intended to be used for the implantation of any type of internal orthopaedic fixation system; the implant(s) is not included. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
214-545-5820schedule@ctlamedica.com

Regulatory Flags#

DUNS number
080138504
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841732144521VALEO II PL OL Interbody Fusion System11.113.45132023-09-22
00841732145474VALEO II PL OL Interbody Fusion System11.113.45092023-09-22
00841732155381VALEO II PL OL Interbody Fusion System11.113.38102023-09-22
00841732155404VALEO II PL OL Interbody Fusion System11.113.38132023-09-22
00841732155411VALEO II PL OL Interbody Fusion System11.113.38142023-09-22
00841732155428VALEO II PL OL Interbody Fusion System11.113.38152023-09-22
00841732155435VALEO II PL OL Interbody Fusion System11.113.45082023-09-22
00841732155442VALEO II PL OL Interbody Fusion System11.113.45102023-09-22
00841732155459VALEO II PL OL Interbody Fusion System11.113.45112023-09-22
00841732155466VALEO II PL OL Interbody Fusion System11.113.45142023-09-22
00841732155923VALEO II PL OL Interbody Fusion System11.113.60072023-09-22
00841732155930VALEO II PL OL Interbody Fusion System11.113.60082023-09-22
00841732155947VALEO II PL OL Interbody Fusion System11.113.60092023-09-22
00841732155954VALEO II PL OL Interbody Fusion System11.113.60102023-09-22
00841732155961VALEO II PL OL Interbody Fusion System11.113.60112023-09-22
00841732155978VALEO II PL OL Interbody Fusion System11.113.60132023-09-22
00841732160200VALEO II PL OL Interbody Fusion System11.113.38112023-09-22
00841732155268VALEO II PL OL Interbody Fusion System11.113.18122023-09-21
00841732155275VALEO II PL OL Interbody Fusion System11.113.18132023-09-21
00841732155299VALEO II PL OL Interbody Fusion System11.113.18152023-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197157075859ZAVATION INSERTERZavation LLCMAX2026-05-27
00810166522366X-PACEXPANDING INNOVATIONS, INC.MAX2026-05-27
00810166522373X-PACEXPANDING INNOVATIONS, INC.MAX2026-05-27
B70712535005S0Dual X Graft Tamp ShortAMPLIFY SURGICAL, INC.MAX2026-05-27
B707129410010130DUALXS T/PLIF 15 DEG x 9-12MMAMPLIFY SURGICAL, INC.MAX2026-05-27
B707129410010200DUALXS T/PLIF 18 DEG x 10-13MMAMPLIFY SURGICAL, INC.MAX2026-05-27
07613153046196AVS PLStryker CorporationMAX2015-09-14
07613153046202AVS PLStryker CorporationMQP2015-09-14
07613153046202AVS PLStryker CorporationMAX2015-09-14
07613153046219AVS PLStryker CorporationMAX2015-09-14
07613153046219AVS PLStryker CorporationMQP2015-09-14
07613153046226AVS PLStryker CorporationMQP2015-09-14
07613153046233AVS PLStryker CorporationMAX2015-09-14
07613153046233AVS PLStryker CorporationMQP2015-09-14
07613153046288AVS PLStryker CorporationMQP2015-09-14
07613153046295AVS PLStryker CorporationMQP2015-09-14
07613153046301AVS PLStryker CorporationMAX2015-09-14
07613153046301AVS PLStryker CorporationMQP2015-09-14
07613153046318AVS PLStryker CorporationMQP2015-09-14
07613153046325AVS PLStryker CorporationMAX2015-09-14
07613153046325AVS PLStryker CorporationMQP2015-09-14
07613153046332AVS PLStryker CorporationMAX2015-09-14
07613153046332AVS PLStryker CorporationMQP2015-09-14
07613153046349AVS PLStryker CorporationMQP2015-09-14
07613153046356AVS PLStryker CorporationMAX2015-09-14
07613153046363AVS PLStryker CorporationMAX2015-09-14
07613153046370AVS PLStryker CorporationMQP2015-09-14
07613153046394AVS TLStryker CorporationMQP2015-09-14
07613153046394AVS TLStryker CorporationMAX2015-09-14
07613153046400AVS TLStryker CorporationMAX2015-09-14