FDA.reportPublic FDA data

LineSider

Primary DI
03662663089104
Brand
LineSider
Company
Highridge Medical, LLC
Model
ASY-00744
Catalog number
ASY-00744
Device description
5.5-6.0mm Polyaxial MG Nav Screw Driver
Published
2025-10-03
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
OLOOrthopedic stereotaxic instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OLOOrthopedic Stereotaxic InstrumentNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K212088000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212088000Integrity Implants Navigated InstrumentsIntegrity Implants, Inc.2021-12-23OLO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03662663089104PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03662663089104036626630891043662663089104

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

Contacts#

Phone, Email table
PhoneEmail
+1(800)447-3625usbrocustomerservice@highridgemedical.com

Regulatory Flags#

DUNS number
119260394
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03662663273350Timberline Lateral Fusion System8734-00308734-00302025-12-18
00887868381034Virage 3.0mm tapered Tap 14mm lengthLV01586LV015862026-04-30
00887868523083The TetherLV01666LV016662026-04-22
008884805002164.75mm Reamer ProbeLV00568LV005682026-04-15
00887868259814Radiolucent Pedicle ProbeLV01446LV014462026-04-07
03662663194457SC-AcuFix Anterior Cervical Plate System457-1457-12026-03-31
03662663194464SC-AcuFix Anterior Cervical Plate System474-1474-12026-03-31
03662663194471SC-AcuFix Anterior Cervical Plate System479-1479-12026-03-31
03662663199155Silhouette Spinal Fixation System7010-0003-007010-0003-002026-03-31
03662663199162Silhouette Spinal Fixation System7010-0011-007010-0011-002026-03-31
03662663199179Silhouette Spinal Fixation System7010-0013-007010-0013-002026-03-31
03662663199186Silhouette Spinal Fixation System7010-0014-007010-0014-002026-03-31
03662663199193Silhouette Spinal Fixation System7010-0015-007010-0015-002026-03-31
03662663199209Silhouette Spinal Fixation System7010-0084-007010-0084-002026-03-31
03662663199216Silhouette Spinal Fixation System7010-0133-007010-0133-002026-03-31
03662663199223Silhouette Spinal Fixation System7010-0152-017010-0152-012026-03-31
03662663130929Zyston Interbody Spacer System136M3306136M33062026-03-17
03662663130936Zyston Interbody Spacer System136M3307136M33072026-03-17
03662663131117Zyston Interbody Spacer System139M2606139M26062026-03-17
03662663136693Polaris 5.5 Spinal Fixation System14-50181014-5018102026-03-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840493422268RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-02
00840493422275RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-02
00840493422282RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-02
00840493422299RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-02
00840493422305RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-02
00840493422312RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-02
00840493422329RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-02
00840493422336RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-02
00840493422343RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-02
00840493422350RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-02
00840493422367RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-02
00840493422374RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-02
00840493422381RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-02
00840493422121RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-01
00840493422138RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-01
00840493422145RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-01
00840493422152RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-01
00840493422169RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-01
00840493422176RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-01
00840493422183RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-01
00840493422190RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-01
00840493422206RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-01
00840493422213RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-01
00840493422220RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-01
00840493422237RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-01
00840493422244RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-01
00840493422251RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-01
M711LS7810Navigation - Vector M-SINNO Holdings, Inc.OLO2026-05-31
M711LS7820Navigation - Vector M-SINNO Holdings, Inc.OLO2026-05-31
M711LS7830Navigation - Vector M-SINNO Holdings, Inc.OLO2026-05-31