FDA.report

CorticaLINK

Primary DI
00817329024088
Brand
CorticaLINK
Company
LINKSPINE, INC.
Model
80-4509/45
Catalog number
80-4509/45
Device description
4.5mm Cortical Tap Solid Body AO
Published
2018-04-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
HWXTap, Bone

Product Code Classifications

CodeDeviceSpecialtyClass
HWXTap, BoneOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00817329024088PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00817329024088008173290240888173290240880817329024088

GMDN Terms

TermDefinition
Bone tap, reusableA metal surgical instrument designed for cutting internal threads into bone so that the threads facilitate the insertion of bone screws. The screws anchor bone fragments, fixtures and/or other devices to the bone. It is made of high-grade stainless steel and has a helical thread intersected with longitudinal cutting grooves forming the cutting edges at its distal end and may be cannulated. The proximal end typically terminates in a square to which a tapping instrument or extension can be attached. It will typically be manually rotated in order to create a best possible thread. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
1-410-772-5465cs@linkspine.com

Regulatory Flags

DUNS number
067584601
Device count
1
DM exempt
false
Premarket exempt
true
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 DIBrandModelCatalogPublished
00817329023500VertebraLINK84-0501/0084-0501/002018-04-24
00817329023517VertebraLINK84-0501/5084-0501/502018-04-24
00817329023555VertebraLINK84-0505/040184-0505/04012018-04-24
00817329023562VertebraLINK84-0505/040284-0505/04022018-04-24
00817329023579VertebraLINK84-0505/040384-0505/04032018-04-24
00817329023586VertebraLINK84-0505/060184-0505/06012018-04-24
00817329023593VertebraLINK84-0505/060284-0505/06022018-04-24
00817329023609VertebraLINK84-0505/060384-0505/06032018-04-24
00817329023616VertebraLINK84-050684-05062018-04-24
00817329023623VertebraLINK84-0508/L84-0508/L2018-04-24
00817329023630VertebraLINK84-0508/R84-0508/R2018-04-24
00817329023647VertebraLINK84-0509/L84-0509/L2018-04-24
00817329023654VertebraLINK84-0509/R84-0509/R2018-04-24
00817329020004CorticaLINK80-400180-40012016-09-30
00817329020011CorticaLINK80-4002/02580-4002/0252016-09-30
00817329020028CorticaLINK80-4002/03080-4002/0302016-09-30
00817329020042CorticaLINK80-4002/04080-4002/0402016-09-30
00817329020097CorticaLINK80-4003/02580-4003/0252016-09-30
00817329020103CorticaLINK80-4003/03080-4003/0302016-09-30
00817329020127CorticaLINK80-4003/04080-4003/0402016-09-30

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