FDA.report

CorticaLINK MI, CorticaLINK, VertebraLINK, VertebraLINK MI, FacetLINK MI

Primary DI
00817329024651
Brand
CorticaLINK MI, CorticaLINK, VertebraLINK, VertebraLINK MI, FacetLINK MI
Company
LINKSPINE, INC.
Model
80-4905
Catalog number
80-4905
Device description
2-Level Outer Tray
Published
2018-07-06
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
LRPTray, Surgical

Product Code Classifications

CodeDeviceSpecialtyClass
LRPTray, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00817329024651PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00817329024651008173290246518173290246510817329024651

GMDN Terms

TermDefinition
Bone-screw internal spinal fixation system, non-sterileAn assembly of non-sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Non-sterile disposable devices associated with implantation may be included.

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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