FDA Registration Active 🇰🇷 South Korea

The Peridot-TD Intervertebral body fusion system

Reg #: 3015136700 · FEI: 3015136700 · Expires 2025
Products
2
Proprietary Names
5
Establishment Types
2
Classifications
2

Registration Details

Registration Name
GBS COMMONWEALTH, CO. LTD.
Registration Number
3015136700
FEI Number
3015136700
Status
Active
Expiry Year
2025
Initial Importer
No
Address
168 Gasan Digital 1-ro, Geumcheon-gu, 309, Woolim Lions Valley C
City
Seoul
Country
KR

Regulatory Submissions

510(k) Number
K233839

Owner / Operator

Firm Name
GBS Commonwealth, Co. Ltd.
Operator Number
10059134
Address
168 Gasan Digital 1-ro, Geumcheon-gu, 309, Woolim Lions Valley C
City
Seoul
State
KR-11
Postal Code
08507
Country
KR

US Agent

Business Name
PMT Republic
Contact Name
Kevin Ahn
Address
20616 truss ct
City
Walnut
State
CA
ZIP
91789
Country
US
Phone
909 5201855

Products

Device Name Product Code
Intervertebral Fusion Device With Bone Graft, Lumbar MAX
Intervertebral Fusion Device With Bone Graft, Cervical ODP

Proprietary Names

The Peridot-TD Intervertebral body fusion system The Peridot-TD Anterior Cervical Intervertebral body fusion system Peridot-PT Anterior Cervical Intervertebral body fusion System Peridot-PT Intervertebral body fusion system Peridot-PT/TD Anterior Cervical Intervertebral body fusion System, Peridot-PT/TD Intervertebral body fusion system

Establishment Types

Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device