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, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented (LPH) (7) Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented (LWJ) (7) Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer (HRY) (3)

Premarket Exempt

No Yes

Clear

Quatro-M Femoral Stem - B046WK110220 Catalog Number : WK-1-1022

Device Description : Quatro-M Femoral Stem 5M

Device Class : 2

Duns Number: 169289308

Premarket Exempt : No

Product Code : LWJ, LPH

Prescription Use : Yes

Device Count : 1

Quatro-M Femoral Stem - B046WK110230 Catalog Number : WK-1-1023

Device Description : Quatro-M Femoral Stem 5L

Device Class : 2

Duns Number: 169289308

Premarket Exempt : No

Product Code : LWJ, LPH

Prescription Use : Yes

Device Count : 1

Quatro-M Femoral Stem - B046WK110240 Catalog Number : WK-1-1024

Device Description : Quatro-M Femoral Stem 5XL

Device Class : 2

Duns Number: 169289308

Premarket Exempt : No

Product Code : LWJ, LPH

Prescription Use : Yes

Device Count : 1

Quatro-M Femoral Stem - B046WK110310 Catalog Number : WK-1-1031

Device Description : Quatro-M Femoral Stem 2XS

Device Class : 2

Duns Number: 169289308

Premarket Exempt : No

Product Code : LPH, LWJ

Prescription Use : Yes

Device Count : 1

Quatro-M Femoral Stem - B046WK110320 Catalog Number : WK-1-1032

Device Description : Quatro-M Femoral Stem 3XS

Device Class : 2

Duns Number: 169289308

Premarket Exempt : No

Product Code : LWJ, LPH

Prescription Use : Yes

Device Count : 1

Quatro-M Femoral Stem - B046WK110330 Catalog Number : WK-1-1033

Device Description : Quatro-M Femoral Stem 4XS

Device Class : 2

Duns Number: 169289308

Premarket Exempt : No

Product Code : LWJ, LPH

Prescription Use : Yes

Device Count : 1

Quatro-M Femoral Stem - B046WK110340 Catalog Number : WK-1-1034

Device Description : Quatro-M Femoral Stem 5XS

Device Class : 2

Duns Number: 169289308

Premarket Exempt : No

Product Code : LWJ, LPH

Prescription Use : Yes

Device Count : 1

Uni Femoral Knee - B046WZ110020 Catalog Number : WZ-1-1002

Device Description : Uni Femoral Knee Size 2

Device Class : 2

Duns Number: 169289308

Premarket Exempt : No

Product Code : HRY

Prescription Use : Yes

Device Count : 1

Uni Femoral Knee - B046WZ110030 Catalog Number : WZ-1-1003

Device Description : Uni Femoral Knee Size 3

Device Class : 2

Duns Number: 169289308

Premarket Exempt : No

Product Code : HRY

Prescription Use : Yes

Device Count : 1

Uni Femoral Knee - B046WZ110040 Catalog Number : WZ-1-1004

Device Description : Uni Femoral Knee Size 4

Device Class : 2

Duns Number: 169289308

Premarket Exempt : No

Product Code : HRY

Prescription Use : Yes

Device Count : 1

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