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

Symmetric Total Knee Tibial Tray - B04622021230 Catalog Number : 22-02-123

Device Description : Symmetric Total Knee Tibial Tray Size: 3

Device Class : 2

Duns Number: 169289308

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

Symmetric Total Knee Tibial Tray - B04622021240 Catalog Number : 22-02-124

Device Description : Symmetric Total Knee Tibial Tray Size 4

Device Class : 2

Duns Number: 169289308

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

Symmetric Total Knee Tibial Tray - B04622021250 Catalog Number : 22-02-125

Device Description : Symmetric Total Knee Tibial Tray Size 5

Device Class : 2

Duns Number: 169289308

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

Symmetric Total Knee Tibial Tray - B04622021260 Catalog Number : 22-02-126

Device Description : Size : 6 Symmetric Total Knee Tibial Tray

Device Class : 2

Duns Number: 169289308

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

Symmetric Total Knee Tibial Tray - B04622021270 Catalog Number : 22-02-127

Device Description : Symmetric Total Knee Tibial Tray Size 7

Device Class : 2

Duns Number: 169289308

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

Standard Tibial Insert - B0462203001030 Catalog Number : 22-03-00-10-3

Device Description : Symmetric Total Knee Standard Tibial Insert Size 3x10

Device Class : 2

Duns Number: 169289308

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

Standard Tibial Insert - B0462203001040 Catalog Number : 22-03-00-10-4

Device Description : Symmetric Total Knee Standard Tibial Insert Size 4x10

Device Class : 2

Duns Number: 169289308

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

Standard Tibial Insert - B0462203001050 Catalog Number : 22-03-00-10-5

Device Description : Symmetric Total Knee Standard Tibial Insert Size 5x10

Device Class : 2

Duns Number: 169289308

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

Standard Tibial Insert - B0462203001060 Catalog Number : 22-03-00-10-6

Device Description : Symmetric Total Knee Standard Tibial Insert Size 6x10

Device Class : 2

Duns Number: 169289308

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

Standard Tibial Insert - B0462203001070 Catalog Number : 22-03-00-10-7

Device Description : Symmetric Total Knee Standard Tibial Insert Size 7x10

Device Class : 2

Duns Number: 169289308

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

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