AESCULAP IMPLANT SYSTEMS, LLC

Address:9999 HAMILTON BLVD., BLDG 8,Breinigsville,PA,18031,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) (8) ORTHOPEDIC MANUAL SURGICAL INSTRUMENT (LXH) (1) TRAY, SURGICAL, INSTRUMENT (FSM) (1)

Premarket Exempt

No Yes

Clear

SPECTRUM - 04038653434336 Catalog Number : FG364T

Device Description : SPECTRUM CERVICAL PLATE 8 HOLES 66MM

Device Class : 2

Duns Number: 622600992

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

SPECTRUM - 04038653434343 Catalog Number : FG365T

Device Description : SPECTRUM CERVICAL PLATE 8 HOLES 69MM

Device Class : 2

Duns Number: 622600992

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

SPECTRUM - 04038653434381 Catalog Number : FG371T

Device Description : SPECTRUM CERVICAL PLATE 10 HOLES 75MM

Device Class : 2

Duns Number: 622600992

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

SPECTRUM - 04038653434398 Catalog Number : FG373T

Device Description : SPECTRUM CERVICAL PLATE 10 HOLES 78MM

Device Class : 2

Duns Number: 622600992

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

SPECTRUM - 04038653434404 Catalog Number : FG374T

Device Description : SPECTRUM CERVICAL PLATE 10 HOLES 81MM

Device Class : 2

Duns Number: 622600992

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

SPECTRUM - 04038653434411 Catalog Number : FG376T

Device Description : SPECTRUM CERVICAL PLATE 10 HOLES 84MM

Device Class : 2

Duns Number: 622600992

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

SPECTRUM - 04038653434428 Catalog Number : FG377T

Device Description : SPECTRUM CERVICAL PLATE 10 HOLES 87MM

Device Class : 2

Duns Number: 622600992

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

SPECTRUM - 04038653434435 Catalog Number : FG379T

Device Description : SPECTRUM CERVICAL PLATE 10 HOLES 90MM

Device Class : 2

Duns Number: 622600992

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

AESCULAP - 04046955071883 Catalog Number : ME468

Device Description : PROSPACE BONE ALIF RING CURETTE STR

Device Class : 1

Duns Number: 622600992

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

AESCULAP - 04046955076314 Catalog Number : MD425

Device Description : DA VINCI S & SI DUAL SCOPE TRAY

Device Class : 1

Duns Number: 622600992

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : No

Device Count : 1

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