FDA.reportPublic FDA data

VersaLink™ Crossbar

Primary DI
07290014064560
Brand
VersaLink™ Crossbar
Company
PREMIA SPINE LTD
Model
82610
Published
2026-10-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
NKBOrthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K182598000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182598000VersaLink™ Fixation SystemPremia Spine, Ltd.2018-11-13NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290014064560PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290014064560072900140645607290014064560

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system rodAn implantable component of a bone-screw internal spinal fixation system in the form of a thin cylinder intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, and also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. This component is designed as a longitudinal (intervertebral) connecting element passing through the system’s implantable screw heads or hooks. It is available in various forms (e.g., straight, curved, rigid, flexible, with varying diameters); flexible types may allow small movements of the spine.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
649220779
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290115935677XL Adaptor871462026-10-20
07290115935905XL Screwdriver CM891972026-10-20
07290115935912Screwdriver CM891732026-10-20
07290115935929Tube for K-wire over a k-wire technique 470mm (Nitinol)892892026-10-20
07290115935936Tube for XL K-Wire 450mm892902026-10-20
07290115935943Tube for K-Wires of 470mm892912026-10-20
07290115935950Tube for K-Wires up to 340mm892922026-10-20
07290014064546VersaLink™ Ring Nut825832026-10-18
07290014064553VersaLink™ Ring Set Screw825822026-10-18
07290014064959VersaLink™ Ring Set Screw Torx865052026-10-18
07290014080126Fusion Rod 50mm831962026-10-18
07290014080133Fusion Rod 70mm831972026-10-18
07290014080140Fusion Rod 90mm831982026-10-18
07290115932461PER Ring Nut884972026-10-18
07290115932478PER Set Screw Torx884982026-10-18
07290115932874Cannulated Screwdriver inner shaft865082026-10-18
07290115932881Cannulated Screwdriver Handle Assy865102026-10-18
07290115935547Rod Holding Forceps832082024-10-01
07290115932812Left Alignment Gauge Superior Crossbars Long831062024-09-03
07290115932829Right Alignment Gauge Superior Crossbars Long831072024-09-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197157122874ZAVATION SCREWZavation LLCNKB2026-10-20
00197157122881ZAVATION SCREWZavation LLCNKB2026-10-20
00197157122898ZAVATION SCREWZavation LLCNKB2026-10-20
00197157122904ZAVATION SCREWZavation LLCNKB2026-10-20
00197157122911ZAVATION SCREWZavation LLCNKB2026-10-20
00197157122928ZAVATION SCREWZavation LLCNKB2026-10-20
00197157122935ZAVATION SCREWZavation LLCNKB2026-10-20
00197157122942ZAVATION SCREWZavation LLCNKB2026-10-20
00197157122959ZAVATION SCREWZavation LLCNKB2026-10-20
00197157122966ZAVATION SCREWZavation LLCNKB2026-10-20
00197157122973ZAVATION SCREWZavation LLCNKB2026-10-20
00197157122980ZAVATION SCREWZavation LLCNKB2026-10-20
00197157122997ZAVATION SCREWZavation LLCNKB2026-10-20
00197157123000ZAVATION SCREWZavation LLCNKB2026-10-20
00197157123017ZAVATION SCREWZavation LLCNKB2026-10-20
00197157123024ZAVATION SCREWZavation LLCNKB2026-10-20
00197157123031ZAVATION SCREWZavation LLCNKB2026-10-20
00197157123048ZAVATION SCREWZavation LLCNKB2026-10-20
00197157123055ZAVATION SCREWZavation LLCNKB2026-10-20
00197157123062ZAVATION SCREWZavation LLCNKB2026-10-20
00197157123079ZAVATION SCREWZavation LLCNKB2026-10-20
00197157123086ZAVATION SCREWZavation LLCNKB2026-10-20
00197157123093ZAVATION SCREWZavation LLCNKB2026-10-20
00197157123109ZAVATION SCREWZavation LLCNKB2026-10-20
00197157123116ZAVATION SCREWZavation LLCNKB2026-10-20
00197157123123ZAVATION SCREWZavation LLCNKB2026-10-20
00197157123130ZAVATION SCREWZavation LLCNKB2026-10-20
00197157123147ZAVATION SCREWZavation LLCNKB2026-10-20
00197157123154ZAVATION SCREWZavation LLCNKB2026-10-20
00197157123161ZAVATION SCREWZavation LLCNKB2026-10-20