FDA.report

Ventura NanoMetalene System

Primary DI
10889981152093
Brand
Ventura NanoMetalene System
Company
SEASPINE ORTHOPEDICS CORPORATION
Model
93-3755
Catalog number
93-3755
Device description
Ventura NM Trial, 9mm x 28mm x 16mm, Lordotic
Published
2017-11-17
Public version status
Update
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
MAXIntervertebral fusion device with bone graft, lumbar

Product Code Classifications

CodeDeviceSpecialtyClass
MAXIntervertebral Fusion Device With Bone Graft, LumbarOrthopedic2

Premarket Submissions

SubmissionSupplement
K173022000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K173022000SeaSpine Ventura NanoMetalene SystemSeaSpine Orthopedics Corporation2017-10-26MAX

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10889981152093PrimaryGS10

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.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(760)727-8399custsvcspine@seaspine.com

Regulatory Flags

DUNS number
079840876
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
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

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