FDA.reportPublic FDA data

VertebraLINK

Primary DI
00817329023593
Brand
VertebraLINK
Company
LINKSPINE, INC.
Model
84-0505/0602
Catalog number
84-0505/0602
Device description
6mm Push Curette
Published
2018-04-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FZSCurette, Surgical, General Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZSCurette, Surgical, General UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817329023593PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817329023593008173290235938173290235930817329023593

GMDN Terms#

Term, Definition table
TermDefinition
Bone curette, reusableA manual surgical instrument designed for cutting and excising bone tissue typically during an orthopaedic or a plastic surgery procedure. It is typically designed as a long, slender instrument with a handle at the proximal end and a concave, spoon-like tip which has a sharp edge, at the distal end, or it may be double-ended, and is used to facilitate the removal of the bone tissue without causing trauma to the surrounding muscles. It is typically made of high-grade stainless steel and is a common instrument of choice for the removal of the bone. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
1-410-772-5465cs@linkspine.com

Regulatory Flags#

DUNS number
067584601
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817329024248CorticaLINK80-452680-45262018-04-25
00817329020004CorticaLINK80-400180-40012016-09-30
00817329020011CorticaLINK80-4002/02580-4002/0252016-09-30
00817329020028CorticaLINK80-4002/03080-4002/0302016-09-30
00817329020035CorticaLINK80-4002/03580-4002/0352016-09-30
00817329020042CorticaLINK80-4002/04080-4002/0402016-09-30
00817329020059CorticaLINK80-4002/05080-4002/0502016-09-30
00817329020066CorticaLINK80-4002/06080-4002/0602016-09-30
00817329020073CorticaLINK80-4002/07080-4002/0702016-09-30
00817329020080CorticaLINK80-4002/10080-4002/1002016-09-30
00817329020097CorticaLINK80-4003/02580-4003/0252016-09-30
00817329020103CorticaLINK80-4003/03080-4003/0302016-09-30
00817329020110CorticaLINK80-4003/03580-4003/0352016-09-30
00817329020127CorticaLINK80-4003/04080-4003/0402016-09-30
00817329020134CorticaLINK80-4003/05080-4003/0502016-09-30
00817329020141CorticaLINK80-4003/06080-4003/0602016-09-30
00817329020158CorticaLINK80-4003/07080-4003/0702016-09-30
00817329020165CorticaLINK80-4003/10080-4003/1002016-09-30
00817329020172CorticaLINK80-4006/452580-4006/45252016-09-30
00817329020189CorticaLINK80-4006/453080-4006/45302016-09-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840183531430BR Surgical, LLCBR Surgical, LLCFZS2026-07-22
00840183532017BR Surgical, LLCBR Surgical, LLCFZS2026-07-22
00840183532024BR Surgical, LLCBR Surgical, LLCFZS2026-07-22
00840183532031BR Surgical, LLCBR Surgical, LLCFZS2026-07-22
18257200087426ALIF DISC PREP,ALLOQUENT - ALIFOrthofix US LLCFZS2026-07-17
18257200104093ALLOQUENT - ALIFOrthofix US LLCFZS2026-07-17
B382SD9147092060Surgical DirectSurgical Direct, Inc.FZS2026-07-09
B382SD9147092120Surgical DirectSurgical Direct, Inc.FZS2026-07-09
B382SD9147092130Surgical DirectSurgical Direct, Inc.FZS2026-07-09
B382SD9147092140Surgical DirectSurgical Direct, Inc.FZS2026-07-09
B382SD9147096450Surgical DirectSurgical Direct, Inc.FZS2026-07-09
B382SD9147096460Surgical DirectSurgical Direct, Inc.FZS2026-07-09
B382SD9147096470Surgical DirectSurgical Direct, Inc.FZS2026-07-09
B382SD9147096510Surgical DirectSurgical Direct, Inc.FZS2026-07-09
B382SD9147096520Surgical DirectSurgical Direct, Inc.FZS2026-07-09
B382SD9147096530Surgical DirectSurgical Direct, Inc.FZS2026-07-09
B382SD9147096540Surgical DirectSurgical Direct, Inc.FZS2026-07-09
B382SD9147096550Surgical DirectSurgical Direct, Inc.FZS2026-07-09
07640139342119ROMEO 2 INSTRUMENTATIONSpineArt SAFZS2025-11-10
04046963939588NOVOCARTAesculap AGFZS2020-04-24
04046963315511NOVOCARTAesculap AGFZS2020-04-23
04046963315528NOVOCARTAesculap AGFZS2020-04-23
10649111094002SklarSKLAR CORPORATIONFZS2019-08-26
10649111094088SklarSKLAR CORPORATIONFZS2019-08-26
10649111017711SklarSKLAR CORPORATIONFZS2019-03-13
10649111017858SklarSKLAR CORPORATIONFZS2019-03-13
10649111018084SklarSKLAR CORPORATIONFZS2019-03-13
10649111018282SklarSKLAR CORPORATIONFZS2019-03-13
10649111018619SklarSKLAR CORPORATIONFZS2019-03-13
10649111161612SklarSKLAR CORPORATIONFZS2019-03-13