ZYGA TECHNOLOGY, INC.

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Sacroiliac Joint Fixation (OUR) (10)

Premarket Exempt

Clear

SImmetry® - 00817672010509 Catalog Number : 10-S08550-01

Device Description : SIJ Implant 8.5mm X 50mm

Device Class : 2

Duns Number: 024049072

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

SImmetry® - 00817672010516 Catalog Number : 10-S08555-01

Device Description : SIJ Implant 8.5mm X 55mm

Device Class : 2

Duns Number: 024049072

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

SImmetry® - 00817672010523 Catalog Number : 10-S08560-01

Device Description : SIJ Implant 8.5mm X 60mm

Device Class : 2

Duns Number: 024049072

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

SImmetry® - 00817672010547 Catalog Number : 10-S08570-01

Device Description : SIJ Implant 8.5mm X 70mm

Device Class : 2

Duns Number: 024049072

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

SImmetry® - 00817672010561 Catalog Number : 10-S08580-01

Device Description : SIJ Implant 8.5mm X 80mm

Device Class : 2

Duns Number: 024049072

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

SImmetry® - 00817672010585 Catalog Number : 10-S08590-01

Device Description : SIJ Implant 8.5mm X 90mm

Device Class : 2

Duns Number: 024049072

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

SImmetry® - 00817672010806 Catalog Number : 10-SL08570-01

Device Description : SIJ Implant 8.5mm X 70mm

Device Class : 2

Duns Number: 024049072

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

SImmetry® - 00817672010820 Catalog Number : 10-SL08580-01

Device Description : SIJ Implant 8.5mm X 80mm

Device Class : 2

Duns Number: 024049072

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

SImmetry® - 00817672010844 Catalog Number : 10-SL08590-01

Device Description : SIJ Implant 8.5mm X 90mm

Device Class : 2

Duns Number: 024049072

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

SImmetry® - 00817672010936 Catalog Number : 10-S10550-01

Device Description : SIJ Implant 10.5mm X 50mm

Device Class : 2

Duns Number: 024049072

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

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