FDA.reportPublic FDA data

Valeo II LL

Primary DI
00841732158672
Brand
Valeo II LL
Company
CTL Medical Corporation
Model
110-329
Device description
K Wire
Published
2024-11-01
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MAXIntervertebral Fusion Device With Bone Graft, LumbarOrthopedic2
ODPIntervertebral Fusion Device With Bone Graft, CervicalOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K121892000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K121892000PHANTOM PLUS CERAMIC CAGE SYSTEMAmedica Corp.2012-08-24MAX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841732158672PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841732158672008417321586728417321586720841732158672

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
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
00841732163447VALEO C Spacer System91.002.40012023-09-30
00841732163454VALEO C Spacer System91.002.40022023-09-30
00841732163461VALEO C Spacer System91.002.40032023-09-30
00841732128231VALEO VBR91.009.56512023-09-27
00841732128248VALEO VBR91.009.56522023-09-27
00841732145511VALEO C+CSC with Lumen Interbody Fusion Device11.209.17072023-09-19
00841732145528VALEO C+CSC with Lumen Interbody Fusion Device11.209.17082023-09-19
00841732145535VALEO C+CSC with Lumen Interbody Fusion Device11.209.17092023-09-19
00841732145542VALEO C+CSC with Lumen Interbody Fusion Device11.209.17102023-09-19
00841732154766VALEO C+CSC with Lumen Interbody Fusion Device11.209.11082023-09-19
00841732154773VALEO C+CSC with Lumen Interbody Fusion Device11.209.11092023-09-19
00841732154780VALEO C+CSC with Lumen Interbody Fusion Device11.209.11102023-09-19
00841732154797VALEO C+CSC with Lumen Interbody Fusion Device11.209.11112023-09-19
00841732154803VALEO C+CSC with Lumen Interbody Fusion Device11.209.17052023-09-19
00841732154810VALEO C+CSC with Lumen Interbody Fusion Device11.209.17062023-09-19
00841732154865VALEO C+CSC with Lumen Interbody Fusion Device11.209.17112023-09-19
00841732149847TAURUS Pedicle Screw System51-1000-0012023-09-15
00841732149854TAURUS Pedicle Screw System51-1000-0022023-09-15
00841732150614GENERIC Surgical Instruments50-1000-0042023-09-15
00841732150621TAURUS Pedicle Screw System51-0000-0002023-09-15

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00843511102135Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102142Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102142Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102159Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102159Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102166Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102166Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102173Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102173Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102180Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102180Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102197Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102197Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102203Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102203Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102210Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102210Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102227Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102227Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102234Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102234Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102241Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102241Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102258Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102258Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102265Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102265Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102272Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102272Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22