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) (10) Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented (LWJ) (10)

Premarket Exempt

No Yes

Clear

Quatro-M Femoral Stem - B046WK110120 Catalog Number : WK-1-1012

Device Description : Quatro-M Femoral Stem 2XL

Device Class : 2

Duns Number: 169289308

Premarket Exempt : No

Product Code : LWJ, LPH

Prescription Use : Yes

Device Count : 1

Quatro-M Femoral Stem - B046WK110130 Catalog Number : WK-1-1013

Device Description : Quatro-M Femoral Stem 3S

Device Class : 2

Duns Number: 169289308

Premarket Exempt : No

Product Code : LPH, LWJ

Prescription Use : Yes

Device Count : 1

Quatro-M Femoral Stem - B046WK110140 Catalog Number : WK-1-1014

Device Description : Quatro-M Femoral Stem 3M

Device Class : 2

Duns Number: 169289308

Premarket Exempt : No

Product Code : LPH, LWJ

Prescription Use : Yes

Device Count : 1

Quatro-M Femoral Stem - B046WK110150 Catalog Number : WK-1-1015

Device Description : Quatro-M Femoral Stem 3L

Device Class : 2

Duns Number: 169289308

Premarket Exempt : No

Product Code : LWJ, LPH

Prescription Use : Yes

Device Count : 1

Quatro-M Femoral Stem - B046WK110160 Catalog Number : WK-1-1016

Device Description : Quatro-M Femoral Stem 3XL

Device Class : 2

Duns Number: 169289308

Premarket Exempt : No

Product Code : LWJ, LPH

Prescription Use : Yes

Device Count : 1

Quatro-M Femoral Stem - B046WK110170 Catalog Number : WK-1-1017

Device Description : Quatro-M Femoral Stem 4S

Device Class : 2

Duns Number: 169289308

Premarket Exempt : No

Product Code : LWJ, LPH

Prescription Use : Yes

Device Count : 1

Quatro-M Femoral Stem - B046WK110180 Catalog Number : WK-1-1018

Device Description : Quatro-M Femoral Stem 4M

Device Class : 2

Duns Number: 169289308

Premarket Exempt : No

Product Code : LWJ, LPH

Prescription Use : Yes

Device Count : 1

Quatro-M Femoral Stem - B046WK110190 Catalog Number : WK-1-1019

Device Description : Quatro-M Femoral Stem 4L

Device Class : 2

Duns Number: 169289308

Premarket Exempt : No

Product Code : LWJ, LPH

Prescription Use : Yes

Device Count : 1

Quatro-M Femoral Stem - B046WK110200 Catalog Number : WK-1-1020

Device Description : Quatro-M Femoral Stem 4XL

Device Class : 2

Duns Number: 169289308

Premarket Exempt : No

Product Code : LWJ, LPH

Prescription Use : Yes

Device Count : 1

Quatro-M Femoral Stem - B046WK110210 Catalog Number : WK-1-1021

Device Description : Quatro-M Femoral Stem 5S

Device Class : 2

Duns Number: 169289308

Premarket Exempt : No

Product Code : LWJ, LPH

Prescription Use : Yes

Device Count : 1

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