EBI, LLC

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

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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) (7) Stimulator, Invasive Bone Growth (LOE) (3)

Premarket Exempt

Clear

EBI OsteoGen™ Implantable Bone Growth Stimulator - 00812301020119 Catalog Number : 10-1348S

Device Description : OSTEOGEN-40/S

Device Class : 3

Duns Number: 050410323

Premarket Exempt : No

Product Code : LOE

Prescription Use : Yes

Device Count : 1

SpF®-PLUS-Mini (60 uA/M) - 00812301020126 Catalog Number : 10-1398M

Device Description : SPF-PLUS 60/M Implantable Spinal Fusion Stimulator

Device Class : 3

Duns Number: 050410323

Premarket Exempt : No

Product Code : LOE

Prescription Use : Yes

Device Count : 1

SpF®-PLUS-Mini (60 uA/W) - 00812301020133 Catalog Number : 10-1398W

Device Description : SPF-PLUS 60/W Implantable Spinal Fusion Stimulator

Device Class : 3

Duns Number: 050410323

Premarket Exempt : No

Product Code : LOE

Prescription Use : Yes

Device Count : 1

Biomet SpinalPak / OrthoPak - 00812301020188 Catalog Number : 106130-12

Device Description : ELECTRODES, LT-4500

Device Class : 3

Duns Number: 050410323

Premarket Exempt : No

Product Code : LOF

Prescription Use : Yes

Device Count : 1

Biomet SpinalPak / OrthoPak - 00812301020195 Catalog Number : 106130-17

Device Description : ELECTRODE COVER PATCHES

Device Class : 3

Duns Number: 050410323

Premarket Exempt : No

Product Code : LOF

Prescription Use : Yes

Device Count : 1

Biomet SpinalPak / OrthoPak - 00812301020201 Catalog Number : 106130-20

Device Description : ELECTRODES 72R, SOFT TOUCHREPLACEMENT

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 - 00812301020218 Catalog Number : 1067716

Device Description : SPINALPAK ASSEMBLY

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 - 00812301020225 Catalog Number : 1067717

Device Description : SPINALPAK STIMULATOR, BIOMET

Device Class : 3

Duns Number: 050410323

Premarket Exempt : No

Product Code : LOF

Prescription Use : Yes

Device Count : 1

Biomet OrthoPak Non-invasive Bone Growth Stimulator System - 00812301020232 Catalog Number : 1067718

Device Description : ORTHOPAK ASSEMBLY

Device Class : 3

Duns Number: 050410323

Premarket Exempt : No

Product Code : LOF

Prescription Use : Yes

Device Count : 1

Biomet OrthoPak Non-invasive Bone Growth Stimulator System - 00812301020249 Catalog Number : 1067719

Device Description : ORTHOPAK STIMULATOR, BIOMET

Device Class : 3

Duns Number: 050410323

Premarket Exempt : No

Product Code : LOF

Prescription Use : Yes

Device Count : 1

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