FDA UDI In Commercial Distribution 🇺🇸 United States

Invictus

DI: 00190376696140 · Model: 14001-S · ALPHATEC SPINE, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Invictus
Primary DI
00190376696140
Version / Model
14001-S
Company Name
ALPHATEC SPINE, INC.
Labeler DUNS
602465783
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2026-04-09
Public Version
1
Public Version Date
2026-04-17
Public Version Status
New
Public Device Record Key
49353d46-e00a-4e97-a61f-d46beae67c21

Device Description

Band, 3.00mm X 900mm

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
No
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
Yes
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

Product Codes

Code Name
OWI Bone fixation cerclage, sublaminar

GMDN Terms

Code Name
44797 Internal spinal fixation system cable

Identifiers

Type ID
Primary 00190376696140

Customer Contacts

Premarket Submissions

Submission Number Supplement Number
K253615 000

Device Sizes

Type Value Unit Text
Length 900 Millimeter
Width 3 Millimeter