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® - 00817672011261 Catalog Number : 10-PL12580-01

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® - 00817672011285 Catalog Number : 10-PL12590-01

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® - 00817672011353 Catalog Number : 10-P14540-01

Device Description : SIJ Implant 14.5mm X 40mm

Device Class : 2

Duns Number: 024049072

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

SImmetry® - 00817672011360 Catalog Number : 10-P14545-01

Device Description : SIJ Implant 14.5mm X 45mm

Device Class : 2

Duns Number: 024049072

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

SImmetry® - 00817672011377 Catalog Number : 10-P14550-01

Device Description : SIJ Implant 14.5mm X 50mm

Device Class : 2

Duns Number: 024049072

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

SImmetry® - 00817672011384 Catalog Number : 10-P14555-01

Device Description : SIJ Implant 14.5mm X 55mm

Device Class : 2

Duns Number: 024049072

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

SImmetry® - 00817672011391 Catalog Number : 10-P14560-01

Device Description : SIJ Implant 14.5mm X 60mm

Device Class : 2

Duns Number: 024049072

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

SImmetry® - 00817672011636 Catalog Number : 10-W08500-01

Device Description : SIJ Washer For Use with SImmetry® SIJ Implant 8.5mm

Device Class : 2

Duns Number: 024049072

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

SImmetry® - 00817672011643 Catalog Number : 10-W10500-01

Device Description : SIJ Washer For Use with SImmetry® SIJ Implant 10.5mm

Device Class : 2

Duns Number: 024049072

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

SImmetry® - 00817672011650 Catalog Number : 10-W12500-01

Device Description : SIJ Washer For Use with SImmetry® SIJ Implant 12.5mm

Device Class : 2

Duns Number: 024049072

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

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