Eisertech, LLC

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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 Interlaminal (KWP) (10) Appliance, Fixation, Spinal Intervertebral Body (KWQ) (10) Orthosis, Spinal Pedicle Fixation (MNI) (10) Orthosis, Spondylolisthesis Spinal Fixation (MNH) (10) Thoracolumbosacral Pedicle Screw System (NKB) (10)

Premarket Exempt

Clear

Pedicle Screw - B5231000024530 Catalog Number : 100002-4530C

Device Description : CANNULATED MODULAR PEDICLE SCREW 4.5 X 30

Device Class : 2

Duns Number: 965627297

Premarket Exempt : No

Product Code : NKB, MNI, KWP, KWQ, MNH

Prescription Use : Yes

Device Count : 1

Pedicle Screw - B5231000025025 Catalog Number : 100002-5025C

Device Description : CANNULATED MODULAR PEDICLE SCREW 5.0 X 25

Device Class : 2

Duns Number: 965627297

Premarket Exempt : No

Product Code : KWQ, KWP, MNH, MNI, NKB

Prescription Use : Yes

Device Count : 1

Pedicle Screw - B5231000025030 Catalog Number : 100002-5030C

Device Description : CANNULATED MODULAR PEDICLE SCREW 5.0 X 30

Device Class : 2

Duns Number: 965627297

Premarket Exempt : No

Product Code : MNH, KWQ, KWP, MNI, NKB

Prescription Use : Yes

Device Count : 1

Pedicle Screw - B5231000025035 Catalog Number : 100002-5035C

Device Description : CANNULATED MODULAR PEDICLE SCREW 5.0 X 35

Device Class : 2

Duns Number: 965627297

Premarket Exempt : No

Product Code : NKB, MNI, KWP, KWQ, MNH

Prescription Use : Yes

Device Count : 1

Pedicle Screw - B5231000025040 Catalog Number : 100002-5040C

Device Description : CANNULATED MODULAR PEDICLE SCREW 5.0 X 40

Device Class : 2

Duns Number: 965627297

Premarket Exempt : No

Product Code : MNH, KWQ, KWP, MNI, NKB

Prescription Use : Yes

Device Count : 1

Pedicle Screw - B5231000025045 Catalog Number : 100002-5045C

Device Description : CANNULATED MODULAR PEDICLE SCREW 5.0 X 45

Device Class : 2

Duns Number: 965627297

Premarket Exempt : No

Product Code : NKB, MNI, KWP, KWQ, MNH

Prescription Use : Yes

Device Count : 1

Pedicle Screw - B5231000025050 Catalog Number : 100002-5050C

Device Description : CANNULATED MODULAR PEDICLE SCREW 5.0 X 50

Device Class : 2

Duns Number: 965627297

Premarket Exempt : No

Product Code : MNH, KWQ, KWP, MNI, NKB

Prescription Use : Yes

Device Count : 1

Pedicle Screw - B5231000025055 Catalog Number : 100002-5055C

Device Description : CANNULATED MODULAR PEDICLE SCREW 5.0 X 55

Device Class : 2

Duns Number: 965627297

Premarket Exempt : No

Product Code : NKB, MNI, KWP, KWQ, MNH

Prescription Use : Yes

Device Count : 1

Pedicle Screw - B5231000025060 Catalog Number : 100002-5060C

Device Description : CANNULATED MODULAR PEDICLE SCREW 5.0 X 60

Device Class : 2

Duns Number: 965627297

Premarket Exempt : No

Product Code : MNH, KWQ, KWP, MNI, NKB

Prescription Use : Yes

Device Count : 1

Pedicle Screw - B5231000025525 Catalog Number : 100002-5525C

Device Description : CANNULATED MODULAR PEDICLE SCREW 5.5 X 25

Device Class : 2

Duns Number: 965627297

Premarket Exempt : No

Product Code : NKB, MNI, KWP, KWQ, MNH

Prescription Use : Yes

Device Count : 1

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