FDA.report

Timberline MPF Lateral Modular Plate Fixation System

Primary DI
03662663253475
Brand
Timberline MPF Lateral Modular Plate Fixation System
Company
Highridge Medical, LLC
Model
8621-5016
Catalog number
8621-5016
Device description
MPF SPACER 18X50X16 14DEG ASSY
Published
2025-11-14
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

Product Codes

CodeName
OVDIntervertebral fusion device with integrated fixation, lumbar

Product Code Classifications

CodeDeviceSpecialtyClass
OVDIntervertebral Fusion Device With Integrated Fixation, LumbarOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
03662663253475PrimaryGS10

GMDN Terms

TermDefinition
Polymeric spinal interbody fusion cageA device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is in the form of a hollow, porous, threaded and/or fenestrated cylindrical or geometrical device made of non-bioabsorbable synthetic polymer [e.g., polyetheretherketone (PEEK)] that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be included with the device.

Device Sizes

TypeValueUnit
Device Size Text, specify0

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
false
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
00810141040007Foundation Surgical InstrumentsFOUNDATION SURGICAL GROUP INCOVD2026-03-05
10889981304713MeridianSeaspine Orthopedics CorporationOVD2026-03-03
10889981304720MeridianSeaspine Orthopedics CorporationOVD2026-03-03
10889981326241REEF LSeaspine Orthopedics CorporationOVD2026-03-03
00840067210710TrellOss®-A SANEXXT SPINE, LLCOVD2026-02-20
00840067210727TrellOss®-A SANEXXT SPINE, LLCOVD2026-02-20
00840067210734TrellOss®-A SANEXXT SPINE, LLCOVD2026-02-20
00840067210741TrellOss®-A SANEXXT SPINE, LLCOVD2026-02-20
00840067210758TrellOss®-A SANEXXT SPINE, LLCOVD2026-02-20
00840067210765TrellOss®-A SANEXXT SPINE, LLCOVD2026-02-20
00840067210772TrellOss®-A SANEXXT SPINE, LLCOVD2026-02-20
00840067210789TrellOss®-A SANEXXT SPINE, LLCOVD2026-02-20
00840067210796TrellOss®-A SANEXXT SPINE, LLCOVD2026-02-20
00840067210802TrellOss®-A SANEXXT SPINE, LLCOVD2026-02-20
00840067210819TrellOss®-A SANEXXT SPINE, LLCOVD2026-02-20
00840067210826TrellOss®-A SANEXXT SPINE, LLCOVD2026-02-20
00840067210833TrellOss®-A SANEXXT SPINE, LLCOVD2026-02-20
00840067210840TrellOss®-A SANEXXT SPINE, LLCOVD2026-02-20
00840067210857TrellOss®-A SANEXXT SPINE, LLCOVD2026-02-20
00840067210864TrellOss®-A SANEXXT SPINE, LLCOVD2026-02-20
00840067210871TrellOss®-A SANEXXT SPINE, LLCOVD2026-02-20
00840067210888TrellOss®-A SANEXXT SPINE, LLCOVD2026-02-20
00840067210895TrellOss®-A SANEXXT SPINE, LLCOVD2026-02-20
00840067210901TrellOss®-A SANEXXT SPINE, LLCOVD2026-02-20
00840067210918TrellOss®-A SANEXXT SPINE, LLCOVD2026-02-20
00840067210925TrellOss®-A SANEXXT SPINE, LLCOVD2026-02-20
00840067210932TrellOss®-A SANEXXT SPINE, LLCOVD2026-02-20
00840067210949TrellOss®-A SANEXXT SPINE, LLCOVD2026-02-20
00840067210956TrellOss®-A SANEXXT SPINE, LLCOVD2026-02-20
00840067210963TrellOss®-A SANEXXT SPINE, LLCOVD2026-02-20