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EUDAMED
FDA 510(k)
FDA PMA
GUDID
~400
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United States
~400
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Class I
~19
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~381
More classes (11)
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IVD for self-testing
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1,000+ devices found
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Manufacturer: Alpha Ai Co., Ltd.
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Device · Manufacturer · Authorizations
Verified
Status
Regime
Registry
Class
SOLCO 4CIS® General Plate System 96-40708
Alpha Ai Co., Ltd.
·
,
FDA registration: United States
Class II
GUDID
on market
None
GUDID
II
SOLCO 4CIS® General Plate System 96-50607
Alpha Ai Co., Ltd.
·
,
FDA registration: United States
Class II
GUDID
on market
None
GUDID
II
SOLCO 4CIS® General Plate System 96-40607
Alpha Ai Co., Ltd.
·
,
FDA registration: United States
Class II
GUDID
on market
None
GUDID
II
SOLCO 4CIS® General Plate System 96-41012
Alpha Ai Co., Ltd.
·
,
FDA registration: United States
Class II
GUDID
on market
None
GUDID
II
SOLCO 4CIS® General Plate System 96-51417
Alpha Ai Co., Ltd.
·
,
FDA registration: United States
Class II
GUDID
on market
None
GUDID
II
SOLCO 4CIS® General Plate System 96-51214
Alpha Ai Co., Ltd.
·
,
FDA registration: United States
Class II
GUDID
on market
None
GUDID
II
SOLCO 4CIS® General Plate System 96-51619
Alpha Ai Co., Ltd.
·
,
FDA registration: United States
Class II
GUDID
on market
None
GUDID
II
SOLCO 4CIS® General Plate System 96-51821
Alpha Ai Co., Ltd.
·
,
FDA registration: United States
Class II
GUDID
on market
None
GUDID
II
4CIS® Spinal System and 4CIS® Low Back System 62-45040
Alpha Ai Co., Ltd.
·
,
FDA registration: United States
Class II
GUDID
on market
None
GUDID
II
4CIS® Spinal System and 4CIS® Low Back System 4142-6550
Alpha Ai Co., Ltd.
·
,
FDA registration: United States
Class II
GUDID
on market
None
GUDID
II
4CIS® Chiron Spinal Fixation System 4345-5500
Alpha Ai Co., Ltd.
·
,
FDA registration: United States
Class II
GUDID
on market
None
GUDID
II
4CIS® Chiron Spinal Fixation System 4338-5350
Alpha Ai Co., Ltd.
·
,
FDA registration: United States
Class II
GUDID
on market
None
GUDID
II
4CIS® Chiron Spinal Fixation System 4145-95D0
Alpha Ai Co., Ltd.
·
,
FDA registration: United States
Class II
GUDID
on market
None
GUDID
II
4CIS® Chiron Spinal Fixation System 4144-9065
Alpha Ai Co., Ltd.
·
,
FDA registration: United States
Class II
GUDID
on market
None
GUDID
II
4CIS® Chiron Spinal Fixation System 4125-65D5
Alpha Ai Co., Ltd.
·
,
FDA registration: United States
Class II
GUDID
on market
None
GUDID
II
4CIS® Chiron Spinal Fixation System 4129-4035
Alpha Ai Co., Ltd.
·
,
FDA registration: United States
Class II
GUDID
on market
None
GUDID
II
4CIS® Chiron Spinal Fixation System 4145-65B5
Alpha Ai Co., Ltd.
·
,
FDA registration: United States
Class II
GUDID
on market
None
GUDID
II
4CIS® Chiron Spinal Fixation System 4126-7565
Alpha Ai Co., Ltd.
·
,
FDA registration: United States
Class II
GUDID
on market
None
GUDID
II
4CIS Vane Spine System 4302-5530
UDI-DI 08806373571954
Alpha Ai Co., Ltd.
·
,
FDA registration: United States
Class II
GUDID
on market
None
GUDID
II
2 variants
See all variants of this device
4CIS® Instrument System 5901-0177
Alpha Ai Co., Ltd.
·
,
FDA registration: United States
Class I
GUDID
on market
None
GUDID
I
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