FDA.report

Invictus

Primary DI
00190376539256
Brand
Invictus
Company
ALPHATEC SPINE, INC.
Model
AIX400-60
Device description
Ti Patient Specific Rod, 6.0mm
Published
2025-06-23
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
true

Related Records

Product Codes

CodeName
NKGPosterior cervical screw system

Product Code Classifications

CodeDeviceSpecialtyClass
NKGPosterior Cervical Screw SystemOrthopedic2

Premarket Submissions

SubmissionSupplement
K232275000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K232275000Invictus® Spinal Fixation SystemAlphatec Spine, Inc.2023-09-27NKB

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00190376539256PrimaryGS10

GMDN Terms

TermDefinition
Bone-screw internal spinal fixation system rodAn implantable component of a bone-screw internal spinal fixation system in the form of a thin cylinder intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, and also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. This component is designed as a longitudinal (intervertebral) connecting element passing through the system’s implantable screw heads or hooks. It is available in various forms (e.g., straight, curved, rigid, flexible, with varying diameters); flexible types may allow small movements of the spine.

Device Sizes

TypeValueUnit
Outer Diameter6Millimeter

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(760)431-9286Regulatory@alphatecspine.com

Regulatory Flags

DUNS number
602465783
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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