FDA.report

Mergence-S Spinal Instrumentation System

Primary DI
03662663068765
Brand
Mergence-S Spinal Instrumentation System
Company
Highridge Medical, LLC
Model
96-101-05081
Catalog number
96-101-05081
Device description
Angled Provisional
Published
2025-11-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
ODPIntervertebral fusion device with bone graft, cervical

Product Code Classifications

CodeDeviceSpecialtyClass
ODPIntervertebral Fusion Device With Bone Graft, CervicalOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
03662663068765PrimaryGS10

GMDN Terms

TermDefinition
Spinal implant trialA copy of a final spinal prosthesis, graft, or other implantable spinal device (e.g., may include intervertebral disc prosthesis, spinal cage, spinal hook) used to validate the proper size of the permanent implant required by the patient, to determine its appropriate position, and/or to verify that the implant site has been cut to the proper dimensions. It can be made of metal or plastic. 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
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
true

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03662663085533FlareHawkASY-00040ASY-000402025-10-03
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