PARAMOUNT SURGICALS, INC.

Address:3475 W Alton Gloor Blvd Ste B,Brownsville,TX,78520,US

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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

Appliance, Fixation, Spinal Intervertebral Body (KWQ) (7) Orthosis, Spinal Pedicle Fixation (MNI) (3) Orthosis, Spondylolisthesis Spinal Fixation (MNH) (3)

Premarket Exempt

Clear

SIMPLEX/SARAL - 00852647007900 Catalog Number : 322-3064

Device Description : 3 LEVEL CERVICAL PLATE 64 MM

Device Class : 2

Duns Number: 015483156

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

SIMPLEX/SARAL - 00852647007917 Catalog Number : 322-3067

Device Description : 3 LEVEL CERVICAL PLATE 67 MM

Device Class : 2

Duns Number: 015483156

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

SIMPLEX/SARAL - 00852647007924 Catalog Number : 322-4075

Device Description : 4 LEVEL CERVICAL PLATE 75 MM

Device Class : 2

Duns Number: 015483156

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

SIMPLEX/SARAL - 00852647007931 Catalog Number : 322-4079

Device Description : 4 LEVEL CERVICAL PLATE 79 MM

Device Class : 2

Duns Number: 015483156

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

SIMPLEX/SARAL - 00852647007948 Catalog Number : 322-4083

Device Description : 4 LEVEL CERVICAL PLATE 83 MM

Device Class : 2

Duns Number: 015483156

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

UNIMAX - 00852647007955 Catalog Number : 150-16

Device Description : BONE SCREW APPLICATOR

Device Class : 2

Duns Number: 015483156

Premarket Exempt : No

Product Code : MNH, MNI

Prescription Use : Yes

Device Count : 1

UNIMAX - 00852647007962 Catalog Number : 150-18

Device Description : LARGE FLANGE NUT APPLICATOR

Device Class : 2

Duns Number: 015483156

Premarket Exempt : No

Product Code : MNH, MNI

Prescription Use : Yes

Device Count : 1

UNIMAX - 00852647007979 Catalog Number : 150-20

Device Description : SMALL FLANGE NUT APPLICATOR

Device Class : 2

Duns Number: 015483156

Premarket Exempt : No

Product Code : MNH, MNI

Prescription Use : Yes

Device Count : 1

SIMPLEX/SARAL - 00852647007986 Catalog Number : 350-600

Device Description : CERVICAL SCREW REMOVER

Device Class : 2

Duns Number: 015483156

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

SIMPLEX/SARAL - 00852647007993 Catalog Number : 350-25140

Device Description : CERVICAL DRILL BIT. 2.5 MM DIAMETER

Device Class : 2

Duns Number: 015483156

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

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