FDA.reportPublic FDA data

ARROW-LOK

Primary DI
00855967006035
Brand
ARROW-LOK
Company
ARROWHEAD DE LLC
Model
1
Catalog number
21-253519
Device description
ARROW-LOK 2.5-3.5mm / Length 19mm, Straight
Published
2016-03-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HTYPin, Fixation, Smooth

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTYPin, Fixation, SmoothOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K100926000
K112675000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K100926000ARROWHEAD FIXATION DEVICEArrow Products, Inc.2010-10-29HTY
K112675000ARROW-LOK DIGITAL SYSTEMArrowhead Medical Device Technologies, LLC2011-12-12HTY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00855967006035PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00855967006035008559670060358559670060350855967006035

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone pin, non-bioabsorbableA small diameter rod typically used for the fixation of a bone fracture or bone grafts, or for an osteotomy or arthrodesis. The rod may be smooth, wholly- or partially-threaded, solid or cannulated, and some designs may be tapered; it is not specific to the clavicle bone. The device is made of a material that is not chemically degraded or absorbed by natural body processes (e.g., implant grade metal, surgical steel, titanium alloy, or carbon fibre). Some designs may have a break-off shank and/or may be coated [e.g., with hydroxyapatite, also known as hydroxylapatite (HA)] to improve purchase in osteoporotic bone and for long-term fixation. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length19Millimeter

Sterilization Methods#

Method table
Method
Radiation Sterilization

Contacts#

Phone, Email table
PhoneEmail
901-853-4366INFO@ArrowheadDevices.com

Regulatory Flags#

DUNS number
054367577
Device count
1
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00855967006004ARROW-LOK121-3535132016-03-23
00855967006011ARROW-LOK121-3535162016-03-23
00855967006028ARROW-LOK127-2535192016-03-23
00855967006042ARROW-LOK121-2535222016-03-23
00855967006059ARROW-LOK121-2535252016-03-23
00855967006066ARROW-LOK121-2535282017-02-18
00855967006073ARROW-LOK121-2535302016-03-23
00855967006080ARROW-LOK121-2535332016-03-23
00855967006097ARROW-LOK121-2535352016-03-23
00855967006110ARROW-LOK121-2535402016-03-23
00855967006127ARROW-LOK121-2535452016-03-23
00855967006134ARROW-LOK121-2535502016-03-23
00855967006141ARROW-LOK127-2535222016-03-23
00855967006158ARROW-LOK127-2535252016-03-23
00855967006165ARROW-LOK127-2535282016-03-23
00855967006172ARROW-LOK127-2535302016-03-23
00855967006189ARROW-LOK127-2535332016-03-23
00855967006196ARROW-LOK127-2535352016-03-23
00855967006394AMDT Mini-Rail1M7322018-09-10
00855967006400AMDT Mini-Rail1M7342018-09-10

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