FDA.reportPublic FDA data

LineSider

Primary DI
00840200401302
Brand
LineSider
Company
Integrity Implants Inc.
Model
LS-N6RE5520
Catalog number
LS-N6RE5520
Device description
5.5/6.0mm, Non-mod Reduction 7.1mm - Dual to Quad, Non-cannulated - 5.5mm x 20mm
Published
2021-02-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KWPAppliance, Fixation, Spinal Interlaminal
NKBThoracolumbosacral Pedicle Screw System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWPAppliance, Fixation, Spinal InterlaminalOrthopedic2
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K203367000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K203367000LineSider™ Spinal SystemIntegrity Implants, Inc.2020-12-03NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840200401302PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840200401302008402004013028402004013020840200401302

GMDN Terms#

Term, Definition table
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 table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
800.201.9300customerservice@integrityimplants.com

Regulatory Flags#

DUNS number
080300717
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810004722507NAASY-00181ASY-001812020-06-03
00810004722514NAASY-00182ASY-001822020-06-03
00810004722491NAASY-00180ASY-001802019-10-07
00810004722521NAASY-00267ASY-002672019-10-07
00810004722538NAASY-00268ASY-002682019-10-07
00810004722545NAASY-00269ASY-002692019-10-07
00810004722552NAASY-00270ASY-002702019-10-07
00810004722569NAASY-00183ASY-001832019-10-07
00810004722576NAASY-00184ASY-001842019-10-07
00810004722736NAASY-00272ASY-002722019-10-07
00810004722743NAASY-00273ASY-002732019-10-07
00840200409926FlareHawkFHTPWB52025-10-02
00840200410595LineSiderASY-001962025-10-02
00840200410656NACMP-03002CMP-030022025-07-17
00810045531014FlareHawkFHTPCS0026TTSFHTPCS0026TTS2022-12-08
00810045531021FlareHawkFHTPCT0026TTSFHTPCT0026TTS2022-12-08
00810045531038FlareHawkFHTPCS0030TTSFHTPCS0030TTS2022-12-08
00810045531045FlareHawkFHTPCT0030TTSFHTPCT0030TTS2022-12-08
00840200407984FlareHawkFHTGCS0023TTFHTGCS0023TT2023-10-16
00840200407991FlareHawkFHTGCT0023TTFHTGCT0023TT2023-10-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840493424712RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424729RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424736RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424743RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424750RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424767RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424774RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424781RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424798RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424804RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424811RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424828RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424835RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424842RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424859RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424866RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424873RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424880RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424897RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424903RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424910RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424927RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424934RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424941RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424958RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424965RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424972RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424989RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424996RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493425009RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13