FDA.report

ActivL

Primary DI
03662663082136
Brand
ActivL
Company
Highridge Medical, LLC
Model
SW967-HM
Catalog number
SW967-HM
Device description
PE-INLAY 12MM
Published
2026-02-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
MJOProsthesis, intervertebral disc

Product Code Classifications

CodeDeviceSpecialtyClass
MJOProsthesis, Intervertebral DiscUnknown3

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
03662663082136PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
03662663082136036626630821363662663082136

GMDN Terms

TermDefinition
Lumbar total intervertebral disc prosthesisAn implantable device designed to replace a dysfunctional intervertebral disc in the lumbar spine. It most commonly has a two-plate design, one plate attaching to the vertebra above and the other to the vertebra below and may have a compressible core component between. It may facilitate some degree of motion and is typically made of metal and/or synthetic polymer materials. This is the complete prosthesis assembly, not individual components.

Sterilization Methods

Method

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
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
03662663082037ActivLHighridge Medical, LLCMJO2026-02-03
03662663082044ActivLHighridge Medical, LLCMJO2026-02-03
03662663082051ActivLHighridge Medical, LLCMJO2026-02-03
03662663082068ActivLHighridge Medical, LLCMJO2026-02-03
03662663082075ActivLHighridge Medical, LLCMJO2026-02-03
03662663082082ActivLHighridge Medical, LLCMJO2026-02-03
03662663082099ActivLHighridge Medical, LLCMJO2026-02-03
03662663082105ActivLHighridge Medical, LLCMJO2026-02-03
03662663082112ActivLHighridge Medical, LLCMJO2026-02-03
03662663082129ActivLHighridge Medical, LLCMJO2026-02-03
03662663082143ActivLHighridge Medical, LLCMJO2026-02-03
03662663082150ActivLHighridge Medical, LLCMJO2026-02-03
03662663082167ActivLHighridge Medical, LLCMJO2026-02-03
03662663082174ActivLHighridge Medical, LLCMJO2026-02-03
03662663082181ActivLHighridge Medical, LLCMJO2026-02-03
03662663082198ActivLHighridge Medical, LLCMJO2026-02-03
03662663082204ActivLHighridge Medical, LLCMJO2026-02-03
03662663082211ActivLHighridge Medical, LLCMJO2026-02-03
03662663082228ActivLHighridge Medical, LLCMJO2026-02-03
03662663082235ActivLHighridge Medical, LLCMJO2026-02-03
03662663082242ActivLHighridge Medical, LLCMJO2026-02-03
03662663082259ActivLHighridge Medical, LLCMJO2026-02-03
03662663082266ActivLHighridge Medical, LLCMJO2026-02-03
03662663082273ActivLHighridge Medical, LLCMJO2026-02-03
03662663082280ActivLHighridge Medical, LLCMJO2026-02-03
03662663082297ActivLHighridge Medical, LLCMJO2026-02-03
03662663082303ActivLHighridge Medical, LLCMJO2026-02-03
03662663082310ActivLHighridge Medical, LLCMJO2026-02-03
03662663082327ActivLHighridge Medical, LLCMJO2026-02-03
03662663082334ActivLHighridge Medical, LLCMJO2026-02-03