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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)
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IVD General
IVD Annex II List A
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Manufacturer: I.T.S. GmbH
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Class
Cancellous Screw, Locking, D=4.2mm, L=40mm, SH, PPS 37422-40-N-S
I.T.S. GmbH
·
,
FDA registration: United States
Class II
GUDID
on market
None
GUDID
II
Cancellous Screw, Locking, D=4.2mm, L=42mm, SH, PPS 37422-42-N-S
I.T.S. GmbH
·
,
FDA registration: United States
Class II
GUDID
on market
None
GUDID
II
Cancellous Screw, Locking, D=4.2mm, L=48mm, SH, PPS 37422-48-N-S
I.T.S. GmbH
·
,
FDA registration: United States
Class II
GUDID
on market
None
GUDID
II
Cancellous Screw, Locking, D=4.2mm, L=50mm, SH, PPS 37422-50-N-S
I.T.S. GmbH
·
,
FDA registration: United States
Class II
GUDID
on market
None
GUDID
II
Cancellous Screw, Locking, D=4.2mm, L=44mm, SH, PPS 37422-44-N-S
I.T.S. GmbH
·
,
FDA registration: United States
Class II
GUDID
on market
None
GUDID
II
Cancellous Screw, Locking, D=4.2mm, L=46mm, SH, PPS 37422-46-N-S
I.T.S. GmbH
·
,
FDA registration: United States
Class II
GUDID
on market
None
GUDID
II
Cancellous Screw, Locking, D=4.2mm, L=55mm, SH, PPS 37422-55-N-S
I.T.S. GmbH
·
,
FDA registration: United States
Class II
GUDID
on market
None
GUDID
II
Cancellous Screw, Locking, D=4.2mm, L=70mm, SH, PPS 37422-70-N-S
I.T.S. GmbH
·
,
FDA registration: United States
Class II
GUDID
on market
None
GUDID
II
Cancellous Screw, Locking, D=4.2mm, L=60mm, SH, PPS 37422-60-N-S
I.T.S. GmbH
·
,
FDA registration: United States
Class II
GUDID
on market
None
GUDID
II
Cancellous Screw, Locking, D=4.2mm, L=65mm, SH, PPS 37422-65-N-S
I.T.S. GmbH
·
,
FDA registration: United States
Class II
GUDID
on market
None
GUDID
II
Cancellous Screw, Locking, D=4.2mm, L=75mm, SH, PPS 37422-75-N-S
I.T.S. GmbH
·
,
FDA registration: United States
Class II
GUDID
on market
None
GUDID
II
Cancellous Screw, Locking, D=4.2mm, L=85mm, SH, PPS 37422-85-N-S
I.T.S. GmbH
·
,
FDA registration: United States
Class II
GUDID
on market
None
GUDID
II
Cancellous Screw, Locking, D=4.2mm, L=90mm, SH, PPS 37422-90-N-S
I.T.S. GmbH
·
,
FDA registration: United States
Class II
GUDID
on market
None
GUDID
II
Cancellous Screw, Locking, D=4.2mm, L=80mm, SH, PPS 37422-80-N-S
I.T.S. GmbH
·
,
FDA registration: United States
Class II
GUDID
on market
None
GUDID
II
Cancellous Screw, Locking, D=4.2mm, L=95mm, SH, PPS 37422-95-N-S
I.T.S. GmbH
·
,
FDA registration: United States
Class II
GUDID
on market
None
GUDID
II
Cortical Screw, D=3.5mm, L=100mm, PPS 32352-100-S
I.T.S. GmbH
·
,
FDA registration: United States
Class II
GUDID
on market
None
GUDID
II
Cortical Screw, D=3.5mm, L=105mm, PPS 32352-105-S
I.T.S. GmbH
·
,
FDA registration: United States
Class II
GUDID
on market
None
GUDID
II
Cortical Screw, D=3.5mm, L=110mm, PPS 32352-110-S
I.T.S. GmbH
·
,
FDA registration: United States
Class II
GUDID
on market
None
GUDID
II
Cortical Screw, D=3.5mm, L=115mm, PPS 32352-115-S
I.T.S. GmbH
·
,
FDA registration: United States
Class II
GUDID
on market
None
GUDID
II
Cortical Screw, D=3.5mm, L=120mm, PPS 32352-120-S
I.T.S. GmbH
·
,
FDA registration: United States
Class II
GUDID
on market
None
GUDID
II
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