FDA.reportPublic FDA data

LineSider

Primary DI
00840200405683
Brand
LineSider
Company
Integrity Implants Inc.
Model
ASY-00388
Catalog number
ASY-00388
Device description
CLOSED HEAD 5.5-6.0MM POLY AXIAL SCREW DRIVER
Published
2022-03-28
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
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
K190360000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190360000LineSider™ Spinal SystemIntegrity Implants, Inc.2019-06-21NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840200405683PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840200405683008402004056838402004056830840200405683

GMDN Terms#

Term, Definition table
TermDefinition
Surgical screwdriver, reusableA non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). The proximal end of the device may have a handle for manual use or a profiled tang that fits into an independent chuck or power driver; it is typically made of metallic and/or polymer materials. This is a reusable device.

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
00197157082130ZAVATION SCREWZavation LLCKWP2026-07-23
00197157082147ZAVATION SCREWZavation LLCKWP2026-07-23
00197157082154ZAVATION SCREWZavation LLCKWP2026-07-23
00197157082161ZAVATION SCREWZavation LLCKWP2026-07-23
00197157082178ZAVATION SCREWZavation LLCKWP2026-07-23
00197157082185ZAVATION SCREWZavation LLCKWP2026-07-23
00197157082192ZAVATION SCREWZavation LLCKWP2026-07-23
00197157082208ZAVATION SCREWZavation LLCKWP2026-07-23
00197157082215ZAVATION SCREWZavation LLCKWP2026-07-23
00197157082222ZAVATION SCREWZavation LLCKWP2026-07-23
00197157082239ZAVATION SCREWZavation LLCKWP2026-07-23
00197157082246ZAVATION SCREWZavation LLCKWP2026-07-23
00197157082253ZAVATION SCREWZavation LLCKWP2026-07-23
00197157082260ZAVATION SCREWZavation LLCKWP2026-07-23
00197157082277ZAVATION SCREWZavation LLCKWP2026-07-23
00197157082284ZAVATION SCREWZavation LLCKWP2026-07-23
00197157082291ZAVATION SCREWZavation LLCKWP2026-07-23
00197157082307ZAVATION SCREWZavation LLCKWP2026-07-23
00197157082314ZAVATION SCREWZavation LLCKWP2026-07-23
00197157082321ZAVATION SCREWZavation LLCKWP2026-07-23
00197157082338ZAVATION SCREWZavation LLCKWP2026-07-23
00197157082345ZAVATION SCREWZavation LLCKWP2026-07-23
00197157082352ZAVATION SCREWZavation LLCKWP2026-07-23
00197157082369ZAVATION SCREWZavation LLCKWP2026-07-23
00197157082376ZAVATION SCREWZavation LLCKWP2026-07-23
00197157082383ZAVATION SCREWZavation LLCKWP2026-07-23
00197157082390ZAVATION SCREWZavation LLCKWP2026-07-23
00197157082406ZAVATION SCREWZavation LLCKWP2026-07-23
00197157082413ZAVATION SCREWZavation LLCKWP2026-07-23
00197157082420ZAVATION SCREWZavation LLCKWP2026-07-23