EBI, LLC

Address:399 Jefferson Rd,PARSIPPANY,NJ,07054,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

Stimulator, Bone Growth, Non-Invasive (LOF) (10)

Premarket Exempt

Clear

Biomet SpinalPak / OrthoPak - 00812301020256 Catalog Number : 1067720

Device Description : BATTERY PACK, REPLACEMENT

Device Class : 3

Duns Number: 050410323

Premarket Exempt : No

Product Code : LOF

Prescription Use : Yes

Device Count : 1

Biomet SpinalPak / OrthoPak - 00812301020263 Catalog Number : 1067721

Device Description : BATTERY PACK CHARGER, REPLACEMENT

Device Class : 3

Duns Number: 050410323

Premarket Exempt : No

Product Code : LOF

Prescription Use : Yes

Device Count : 1

Biomet SpinalPak / OrthoPak - 00812301020270 Catalog Number : 1067722

Device Description : STIMULATOR HOLSTER, REPLACEMENT

Device Class : 3

Duns Number: 050410323

Premarket Exempt : No

Product Code : LOF

Prescription Use : Yes

Device Count : 1

Biomet SpinalPak / OrthoPak - 00812301020287 Catalog Number : 1067723

Device Description : EXTREMITY BAND, REPLACEMENT

Device Class : 3

Duns Number: 050410323

Premarket Exempt : No

Product Code : LOF

Prescription Use : Yes

Device Count : 1

Biomet SpinalPak / OrthoPak - 00812301020294 Catalog Number : 1067724-1

Device Description : 12" LEAD WIRES, REPLACEMENT

Device Class : 3

Duns Number: 050410323

Premarket Exempt : No

Product Code : LOF

Prescription Use : Yes

Device Count : 1

Biomet SpinalPak / OrthoPak - 00812301020300 Catalog Number : 1067724-2

Device Description : 20" LEAD WIRES, REPLACEMENT

Device Class : 3

Duns Number: 050410323

Premarket Exempt : No

Product Code : LOF

Prescription Use : Yes

Device Count : 1

Biomet SpinalPak / OrthoPak - 00812301020317 Catalog Number : 1067724-3

Device Description : 30" LEAD WIRES, REPLACEMENT

Device Class : 3

Duns Number: 050410323

Premarket Exempt : No

Product Code : LOF

Prescription Use : Yes

Device Count : 1

Biomet SpinalPak / OrthoPak - 00812301020324 Catalog Number : 1067724-4

Device Description : 48" LEAD WIRES, REPLACEMENT

Device Class : 3

Duns Number: 050410323

Premarket Exempt : No

Product Code : LOF

Prescription Use : Yes

Device Count : 1

Biomet SpinalPak / OrthoPak - 00812301020331 Catalog Number : 1067724-5

Device Description : 72" LEAD WIRES, REPLACEMENT

Device Class : 3

Duns Number: 050410323

Premarket Exempt : No

Product Code : LOF

Prescription Use : Yes

Device Count : 1

Biomet SpinalPak Non-invasive Spine Fusion Stimulator System - 00812301020348 Catalog Number : 1067725

Device Description : SPINALPAK ASSEMBLY - ROW

Device Class : 3

Duns Number: 050410323

Premarket Exempt : No

Product Code : LOF

Prescription Use : Yes

Device Count : 1

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