FDA.reportPublic FDA data

Valor®

Primary DI
00840420125552
Brand
Valor®
Company
WRIGHT MEDICAL TECHNOLOGY, INC.
Model
415101030R
Catalog number
415101030R
Published
2015-10-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HSBRod, Fixation, Intramedullary And Accessories
HWCScrew, fixation, bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSBRod, Fixation, Intramedullary And AccessoriesOrthopedic2
HWCScrew, Fixation, BoneOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K082320000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K082320000DARCO SMALL SCREWWrightmedicaltechnologyinc2008-11-05HWC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840420125552PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840420125552008404201255528404201255520840420125552

GMDN Terms#

Term, Definition table
TermDefinition
Arthrodesis nail, sterileA sterile rod made of metal or other material (e.g., carbon fibre) designed to be inserted into the intramedullary canal of any long bone [e.g., femur, tibia, humerus (including fixation of the glenoid), talus, fibula, radius, ulna] to immobilize by holding the ends of a fractured or diseased bone together (i.e., in position) for the purpose of joint fusion or arthrodesis (an operation to permanently fix a joint in position). The device is used for traumatic repair or reconstructive procedures; it may include screws if locked into place. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Length300Millimeter
Outer Diameter10Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)238-7117customerservice@wmt.com

Regulatory Flags#

DUNS number
807201207
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889797076586INVISION60004403600044032022-05-31
00840420167606INVISION600044032016-02-26
00840420106254DARCODC0043162015-10-01
00840420106261DARCODC0043182015-10-01
00840420106278DARCODC0043202015-10-01
00840420106285DARCODC0043222015-10-01
00840420106292DARCODC0043242015-10-01
00889797023443INVISION600025012016-09-17
00889797024136INVISION600124002016-09-17
00889797024143INVISION600124012016-09-17
00889797040686NA49411XL2016-09-17
00889797040693NA49412XL2016-09-17
00889797040709NA49413XL2016-09-17
00889797057295EZ FRAMEEF0037002015-10-24
00889797058452EZ FRAME SIDEKICKEF0016002016-09-17
00889797102957NAEF002550EF0025502022-06-23
00889797103084NAEF003005EF0030052022-06-23
00889797103107NAEF003700EF0037002022-06-23
00889797103091NAEF003010EF0030102022-06-23
00889797103046NAEF001600EF0016002022-05-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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07613154320295MATTAStryker GmbHHWC2023-10-20
07613154320301MATTAStryker GmbHHWC2023-10-20
07613154320318MATTAStryker GmbHHWC2023-10-20
07613154320424MATTAStryker GmbHHWC2023-10-20
07613154320431MATTAStryker GmbHHWC2023-10-20
07613154320448MATTAStryker GmbHHWC2023-10-20
07613154320462MATTAStryker GmbHHWC2023-10-20
07613154320486MATTAStryker GmbHHWC2023-10-20
07613154320493MATTAStryker GmbHHWC2023-10-20
07613154320509MATTAStryker GmbHHWC2023-10-20
07613154320523MATTAStryker GmbHHWC2023-10-20
07613154320554MATTAStryker GmbHHWC2023-10-20
07613154320592MATTAStryker GmbHHWC2023-10-20
07613154320615MATTAStryker GmbHHWC2023-10-20
07613154320639MATTAStryker GmbHHWC2023-10-20
07613154320646MATTAStryker GmbHHWC2023-10-20
07613154320660MATTAStryker GmbHHWC2023-10-20
07613154320684MATTAStryker GmbHHWC2023-10-20
07613154320691MATTAStryker GmbHHWC2023-10-20
07613154320769MATTAStryker GmbHHWC2023-10-20
07613154320776MATTAStryker GmbHHWC2023-10-20
07613154320820MATTAStryker GmbHHWC2023-10-20
07613154320837MATTAStryker GmbHHWC2023-10-20
07613154320844MATTAStryker GmbHHWC2023-10-20
07613154320851MATTAStryker GmbHHWC2023-10-20
07613154320868MATTAStryker GmbHHWC2023-10-20
07613154320875MATTAStryker GmbHHWC2023-10-20
07613154320899MATTAStryker GmbHHWC2023-10-20
07613154320912MATTAStryker GmbHHWC2023-10-20