ZYGA TECHNOLOGY, INC.

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

No

Clear

SImmetry® - 00817672010066 Catalog Number : 10-P12540-01

Device Description : SIJ Implant 12.5mm X 40mm

Device Class : 2

Duns Number: 024049072

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

SImmetry® - 00817672010073 Catalog Number : 10-P12550-01

Device Description : SIJ Implant 12.5mm X 50mm

Device Class : 2

Duns Number: 024049072

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

SImmetry® - 00817672010080 Catalog Number : 10-P12560-01

Device Description : SIJ Implant 12.5mm X 60mm

Device Class : 2

Duns Number: 024049072

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

SImmetry® - 00817672010097 Catalog Number : 10-P12570-01

Device Description : SIJ Implant 12.5mm X 70mm

Device Class : 2

Duns Number: 024049072

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

SImmetry® - 00817672010356 Catalog Number : 10-P12545-01

Device Description : SIJ Implant 12.5mm X 45mm

Device Class : 2

Duns Number: 024049072

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

SImmetry® - 00817672010363 Catalog Number : 10-P12555-01

Device Description : SIJ Implant 12.5mm X 55mm

Device Class : 2

Duns Number: 024049072

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

SImmetry® - 00817672010394 Catalog Number : 10-P12580-01

Device Description : SIJ Implant 12.5mm X 80mm

Device Class : 2

Duns Number: 024049072

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

SImmetry® - 00817672010417 Catalog Number : 10-P12590-01

Device Description : SIJ Implant 12.5mm X 90mm

Device Class : 2

Duns Number: 024049072

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

SImmetry® - 00817672010486 Catalog Number : 10-S08540-01

Device Description : SIJ Implant 8.5mm X 40mm

Device Class : 2

Duns Number: 024049072

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

SImmetry® - 00817672010493 Catalog Number : 10-S08545-01

Device Description : SIJ Implant 8.5mm X 45mm

Device Class : 2

Duns Number: 024049072

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

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