FDA.report

VertebraLINK

Primary DI
00817329025146
Brand
VertebraLINK
Company
LINKSPINE, INC.
Model
84-0700/90
Catalog number
84-0700/90
Device description
Long Nerve Root Retractor
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
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications

CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00817329025146PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00817329025146008173290251468173290251460817329025146

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

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00198506090998ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091001ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091018ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091025ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091032ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091049ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091056ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091063ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091070ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091087ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00841523181360Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
00841523181681Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
00841523181698Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
00841523181704Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
00841523181711Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
00841523181728Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
00841523181735Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
00841523181742Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
00841523181759Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
00841523181766Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
00841523181773Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
00841523181780Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
00841523181797Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
00841523181803Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
00841523181810Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
00841523181827Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
00841523181834Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
00841523181841Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
00841523181858Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
00841523181865Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26