SIGNAL MEDICAL CORPORATION

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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

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer (JWH) (10)

Premarket Exempt

No Yes

Clear

Standard Tibial Insert - B0462203001630 Catalog Number : 22-03-00-16-3

Device Description : Symmetric Total Knee Standard Tibial Insert Size 3x16

Device Class : 2

Duns Number: 169289308

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

Standard Tibial Insert - B0462203001640 Catalog Number : 22-03-00-16-4

Device Description : Symmetric Total Knee Standard Tibial Insert Size 4x16

Device Class : 2

Duns Number: 169289308

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

Standard Tibial Insert - B0462203001650 Catalog Number : 22-03-00-16-5

Device Description : Symmetric Total Knee Standard Tibial Insert Size 5x16

Device Class : 2

Duns Number: 169289308

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

Standard Tibial Insert - B0462203001660 Catalog Number : 22-03-00-16-6

Device Description : Symmetric Total Knee Standard Tibial Insert Size 6x16

Device Class : 2

Duns Number: 169289308

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

Standard Tibial Insert - B0462203001670 Catalog Number : 22-03-00-16-7

Device Description : Symmetric Total Knee Standard Tibial Insert Size 7x16

Device Class : 2

Duns Number: 169289308

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

Standard Tibial Insert - B0462203001830 Catalog Number : 22-03-00-18-3

Device Description : Symmetric Total Knee Standard Tibial Insert Size 3x18

Device Class : 2

Duns Number: 169289308

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

Standard Tibial Insert - B0462203001840 Catalog Number : 22-03-00-18-4

Device Description : Symmetric Total Knee Standard Tibial Insert Size 4x18

Device Class : 2

Duns Number: 169289308

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

Standard Tibial Insert - B0462203001850 Catalog Number : 22-03-00-18-5

Device Description : Symmetric Total Knee Standard Tibial Insert Size 5x18

Device Class : 2

Duns Number: 169289308

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

Standard Tibial Insert - B0462203001860 Catalog Number : 22-03-00-18-6

Device Description : Symmetric Total Knee Standard Tibial Insert Size 6x18

Device Class : 2

Duns Number: 169289308

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

Standard Tibial Insert - B0462203001870 Catalog Number : 22-03-00-18-7

Device Description : Symmetric Total Knee Standard Tibial Insert Size 7x18

Device Class : 2

Duns Number: 169289308

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

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