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65 devices found
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Manufacturer: CG Bio Co., Ltd.
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Device · Manufacturer · Authorizations
Verified
Status
Regime
Registry
Class
Curasys 2 (EMDN0003)
CG Bio Co., Ltd.
·
,
South Korea
(FDA 510(k) applicant)
Class II
FDA 510(k)
K253199
Active
Cleared 23 Jun 2026
Active
510(k)
510(k)
II
LumFix Spinal Fixation System CROSSB15076
CG Bio Co., Ltd.
·
,
South Korea
(FDA 510(k) applicant)
Class II
GUDID
on market
None
GUDID
II
LumFix spinal fixation system RDPS5030
CG Bio Co., Ltd.
·
,
South Korea
(FDA 510(k) applicant)
Class II
GUDID
on market
None
GUDID
II
LumFix Spinal Fixation System DPS7540
CG Bio Co., Ltd.
·
,
South Korea
(FDA 510(k) applicant)
Class II
GUDID
on market
None
GUDID
II
LumFix Spinal Fixation System DPS6540
CG Bio Co., Ltd.
·
,
South Korea
(FDA 510(k) applicant)
Class II
GUDID
on market
None
GUDID
II
LumFix Spinal Fixation System RDPS7550
CG Bio Co., Ltd.
·
,
South Korea
(FDA 510(k) applicant)
Class II
GUDID
on market
None
GUDID
II
LumFix Spinal Fixation System RODST55100
CG Bio Co., Ltd.
·
,
South Korea
(FDA 510(k) applicant)
Class II
GUDID
on market
None
GUDID
II
LumFix Spinal Fixation System DPS7545
CG Bio Co., Ltd.
·
,
South Korea
(FDA 510(k) applicant)
Class II
GUDID
on market
None
GUDID
II
LumFix Spinal Fixation System RDPS6540
CG Bio Co., Ltd.
·
,
South Korea
(FDA 510(k) applicant)
Class II
GUDID
on market
None
GUDID
II
LumFix Spinal Fixation System RDPS5540
CG Bio Co., Ltd.
·
,
South Korea
(FDA 510(k) applicant)
Class II
GUDID
on market
None
GUDID
II
LumFix Spinal Fixation System CROSSB13546
CG Bio Co., Ltd.
·
,
South Korea
(FDA 510(k) applicant)
Class II
GUDID
on market
None
GUDID
II
LumFix Spinal Fixation System RDPS5545
CG Bio Co., Ltd.
·
,
South Korea
(FDA 510(k) applicant)
Class II
GUDID
on market
None
GUDID
II
LumFix Spinal Fixation System DPS5550
CG Bio Co., Ltd.
·
,
South Korea
(FDA 510(k) applicant)
Class II
GUDID
on market
None
GUDID
II
LumFix Spinal Fixation System RDPS6045
CG Bio Co., Ltd.
·
,
South Korea
(FDA 510(k) applicant)
Class II
GUDID
on market
None
GUDID
II
LumFix Spinal Fixation System RODCR5580
CG Bio Co., Ltd.
·
,
South Korea
(FDA 510(k) applicant)
Class II
GUDID
on market
None
GUDID
II
LumFix Spinal Fixation System RODST55300
CG Bio Co., Ltd.
·
,
South Korea
(FDA 510(k) applicant)
Class II
GUDID
on market
None
GUDID
II
LumFix Spinal Fixation System DPS6555
CG Bio Co., Ltd.
·
,
South Korea
(FDA 510(k) applicant)
Class II
GUDID
on market
None
GUDID
II
LumFix Spinal Fixation System CRODST55400
CG Bio Co., Ltd.
·
,
South Korea
(FDA 510(k) applicant)
Class II
GUDID
on market
None
GUDID
II
LumFix Spinal Fixation System CRODST55500
CG Bio Co., Ltd.
·
,
South Korea
(FDA 510(k) applicant)
Class II
GUDID
on market
None
GUDID
II
LumFix Spinal Fixation System RDPS7540
CG Bio Co., Ltd.
·
,
South Korea
(FDA 510(k) applicant)
Class II
GUDID
on market
None
GUDID
II
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