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EUDAMED
FDA 510(k)
FDA PMA
GUDID
~400
Country / market
United States
~400
Risk class
Class I
~5
Class IIa
Class IIb
Class III
Class II (US)
~395
More classes (11)
Class A
Class B
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Class D
IVD General
IVD Annex II List A
IVD Annex II List B
IVD for self-testing
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Manufacturer: I.T.S. GmbH
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Class
Cancellous Screw, Locking, D=5.9mm, L=18mm 37592-18
I.T.S. GmbH
·
,
FDA registration: United States
Class II
GUDID
on market
None
GUDID
II
Cancellous Screw, Locking, D=5.9mm, L=34mm 37592-34
I.T.S. GmbH
·
,
FDA registration: United States
Class II
GUDID
on market
None
GUDID
II
Cancellous Screw, Locking, D=5.9mm, L=30mm 37592-30
I.T.S. GmbH
·
,
FDA registration: United States
Class II
GUDID
on market
None
GUDID
II
Cancellous Screw, Locking, D=5.9mm, L=22mm 37592-22
I.T.S. GmbH
·
,
FDA registration: United States
Class II
GUDID
on market
None
GUDID
II
Cancellous Screw, Locking, D=5.9mm, L=38mm 37592-38
I.T.S. GmbH
·
,
FDA registration: United States
Class II
GUDID
on market
None
GUDID
II
Cancellous Screw, Locking, D=5.9mm, L=46mm 37592-46
I.T.S. GmbH
·
,
FDA registration: United States
Class II
GUDID
on market
None
GUDID
II
Cancellous Screw, Locking, D=5.9mm, L=42mm 37592-42
I.T.S. GmbH
·
,
FDA registration: United States
Class II
GUDID
on market
None
GUDID
II
Cancellous Screw, Locking, D=5.9mm, L=50mm 37592-50
I.T.S. GmbH
·
,
FDA registration: United States
Class II
GUDID
on market
None
GUDID
II
Cancellous Screw, Locking, D=5.9mm, L=54mm 37592-54
I.T.S. GmbH
·
,
FDA registration: United States
Class II
GUDID
on market
None
GUDID
II
Cancellous Screw, Locking, D=5.9mm, L=58mm 37592-58
I.T.S. GmbH
·
,
FDA registration: United States
Class II
GUDID
on market
None
GUDID
II
Cortical Screw, D=2.7mm, L=11mm 32271-11
I.T.S. GmbH
·
,
FDA registration: United States
Class II
GUDID
on market
None
GUDID
II
Cancellous Screw, D=5.9mm, L=16mm, Threaded, PPS 30591-16-S
I.T.S. GmbH
·
,
FDA registration: United States
Class II
GUDID
on market
None
GUDID
II
Cancellous Screw, D=5.9mm, L=20mm, Threaded, PPS 30591-20-S
I.T.S. GmbH
·
,
FDA registration: United States
Class II
GUDID
on market
None
GUDID
II
Cancellous Screw, D=5.9mm, L=24mm, Threaded, PPS 30591-24-S
I.T.S. GmbH
·
,
FDA registration: United States
Class II
GUDID
on market
None
GUDID
II
Cancellous Screw, D=5.9mm, L=28mm, Threaded, PPS 30591-28-S
I.T.S. GmbH
·
,
FDA registration: United States
Class II
GUDID
on market
None
GUDID
II
Cancellous Screw, D=5.9mm, L=32mm, Threaded, PPS 30591-32-S
I.T.S. GmbH
·
,
FDA registration: United States
Class II
GUDID
on market
None
GUDID
II
Cancellous Screw, D=5.9mm, L=36mm, Threaded, PPS 30591-36-S
I.T.S. GmbH
·
,
FDA registration: United States
Class II
GUDID
on market
None
GUDID
II
Cancellous Screw, D=5.9mm, L=40mm, Threaded, PPS 30591-40-S
I.T.S. GmbH
·
,
FDA registration: United States
Class II
GUDID
on market
None
GUDID
II
Cancellous Screw, D=5.9mm, L=44mm, Threaded, PPS 30591-44-S
I.T.S. GmbH
·
,
FDA registration: United States
Class II
GUDID
on market
None
GUDID
II
Cancellous Screw, D=5.9mm, L=48mm, Threaded, PPS 30591-48-S
I.T.S. GmbH
·
,
FDA registration: United States
Class II
GUDID
on market
None
GUDID
II
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