FDA.report

Timberline Lateral Fusion System

Primary DI
03662663266710
Brand
Timberline Lateral Fusion System
Company
Highridge Medical, LLC
Model
8732-5414
Catalog number
8732-5414
Device description
TIM ROTATING DISC CUTTER 14MM
Published
2025-12-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
FZTCUTTER, SURGICAL

Product Code Classifications

CodeDeviceSpecialtyClass
FZTCutter, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
03662663266710PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
03662663266710036626632667103662663266710

GMDN Terms

TermDefinition
Bone cutterA strongly constructed, hand-held, surgical instrument designed to separate a bone into two parts through a cutting action. It typically consists of an instrument having one or two sharp robust blades that close over the bone and cut it. It is available in various designs: 1) a pliers-like design with elongated blades, or 2) twin angled blades attached to strong, sprung (self-opening), pivoted or multi-pivoted handles; that, when squeezed together, close the blades so that they cut entirely through the bone. Also known as bone shears, it is mainly used in orthopaedic surgical procedures and oral surgery. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(800)447-3625usbrocustomerservice@highridgemedical.com

Regulatory Flags

DUNS number
119260394
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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
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
03662663136709Polaris 5.5 Spinal Fixation System14-50181114-5018112026-03-17
03662663136723Polaris 5.5 Spinal Fixation System14-50181314-5018132026-03-17
03662663143462MaxAn Anterior Cervical Plate System14-52203814-5220382026-03-17
03662663143479MaxAn Anterior Cervical Plate System14-52203914-5220392026-03-17
03662663143486MaxAn Anterior Cervical Plate System14-52204014-5220402026-03-17
03662663143493MaxAn Anterior Cervical Plate System14-52204114-5220412026-03-17
03662663143509MaxAn Anterior Cervical Plate System14-52204214-5220422026-03-17
03662663143516MaxAn Anterior Cervical Plate System14-52204314-5220432026-03-17
03662663143523MaxAn Anterior Cervical Plate System14-52204414-5220442026-03-17
03662663143530MaxAn Anterior Cervical Plate System14-52204514-5220452026-03-17
03662663085458FlareHawkASY-00003ASY-000032025-10-03
03662663085502FlareHawkASY-00018ASY-000182025-10-03
03662663085533FlareHawkASY-00040ASY-000402025-10-03
03662663085540FlareHawkASY-00041ASY-000412025-10-03
03662663085632FlareHawkASY-00064ASY-000642025-10-03
03662663085663FlareHawkASY-00067ASY-000672025-10-03

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
03662663129053Lineum Occipito-Cervico-Thoracic (OCT) Spinal Fixation SystemHighridge Medical, LLCFZT2026-02-11
10889981087968GeneralSeaspine Orthopedics CorporationFZT2025-12-19
10889981087975GeneralSeaspine Orthopedics CorporationFZT2025-12-19
10889981087982GeneralSeaspine Orthopedics CorporationFZT2025-12-19
10889981095970GeneralSeaspine Orthopedics CorporationFZT2025-12-19
10889981106058CoralSeaspine Orthopedics CorporationFZT2025-12-19
10889981123932GeneralSeaspine Orthopedics CorporationFZT2025-12-19
10889981259921NorthStarSeaspine Orthopedics CorporationFZT2025-12-19
03662663278096Timberline Lateral Fusion SystemHighridge Medical, LLCFZT2025-12-18
03662663217699Vail OCT Spinal Fixation SystemHighridge Medical, LLCFZT2025-12-17
03662663266635Timberline Lateral Fusion SystemHighridge Medical, LLCFZT2025-12-16
03662663266642Timberline Lateral Fusion SystemHighridge Medical, LLCFZT2025-12-16
03662663266659Timberline Lateral Fusion SystemHighridge Medical, LLCFZT2025-12-16
03662663266666Timberline Lateral Fusion SystemHighridge Medical, LLCFZT2025-12-16
03662663266673Timberline Lateral Fusion SystemHighridge Medical, LLCFZT2025-12-16
03662663266680Timberline Lateral Fusion SystemHighridge Medical, LLCFZT2025-12-16
03662663266697Timberline Lateral Fusion SystemHighridge Medical, LLCFZT2025-12-16
03662663266703Timberline Lateral Fusion SystemHighridge Medical, LLCFZT2025-12-16
03662663266727Timberline Lateral Fusion SystemHighridge Medical, LLCFZT2025-12-16
03662663266734Timberline Lateral Fusion SystemHighridge Medical, LLCFZT2025-12-16
03662663266741Timberline Lateral Fusion SystemHighridge Medical, LLCFZT2025-12-16
03662663266758Timberline Lateral Fusion SystemHighridge Medical, LLCFZT2025-12-16
03662663266765Timberline Lateral Fusion SystemHighridge Medical, LLCFZT2025-12-16
03662663266772Timberline Lateral Fusion SystemHighridge Medical, LLCFZT2025-12-16
03662663278799Timberline Lateral Fusion SystemHighridge Medical, LLCFZT2025-12-16
03662663278805Timberline Lateral Fusion SystemHighridge Medical, LLCFZT2025-12-16
03662663278812Timberline Lateral Fusion SystemHighridge Medical, LLCFZT2025-12-16
03662663278829Timberline Lateral Fusion SystemHighridge Medical, LLCFZT2025-12-16
03662663278836Timberline Lateral Fusion SystemHighridge Medical, LLCFZT2025-12-16
03662663278843Timberline Lateral Fusion SystemHighridge Medical, LLCFZT2025-12-16