FDA UDI In Commercial Distribution 🇺🇸 United States

LnK Lumbar Interbody Fusion Cage System

DI: 08806344300378 · Model: 3820-4009 · L&K BIOMED CO. ,LTD.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
LnK Lumbar Interbody Fusion Cage System
Primary DI
08806344300378
Version / Model
3820-4009
Catalog Number
3820-4009
Company Name
L&K BIOMED CO. ,LTD.
Labeler DUNS
631159324
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2015-11-15
Public Version
4
Public Version Date
2020-02-24
Public Version Status
Update
Public Device Record Key
47e2d081-6891-49be-b820-1c4d114f73a2

Device Description

L&K Biomed DLIF PEEK Cage 20 x 40 0 9mm 1EA, LLIF PEEK Cage, 0︒, 20x40x9mm

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
No
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
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
Yes
Sterilization Methods
Moist Heat or Steam Sterilization

Product Codes

Code Name
MAX Intervertebral Fusion Device With Bone Graft, Lumbar

GMDN Terms

Code Name
60762 Polymeric spinal interbody fusion cage

Identifiers

Type ID
Primary 08806344300378