Biomet Spine (Aka Ebi, LLC)
Parsippany, NJ, US
Biomet Spine (Aka Ebi, LLC) appears in FDA device records in Parsippany, NJ. FDA records list 13 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 13
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 13 510(k) clearances for Biomet Spine (Aka Ebi, LLC) between 2010 and 2014. The busiest year on record is 2012, with 4. The most recent is 2014, with 4.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2010 | 2 |
| 2011 | 1 |
| 2012 | 4 |
| 2013 | 2 |
| 2014 | 4 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K133518 | MAXAN ANTERIOR CERVICAL PLATE SYSTEM | KWQ | Substantially Equivalent | |
| K140710 | BIOMET GRAFT DELIVERY SYRINGES | FMF | Substantially Equivalent | |
| K132373 | BIOMET ACCESS SYSTEM | PDQ | Substantially Equivalent | |
| K133746 | POLARIS SPINAL SYSTEM | NKB | Substantially Equivalent | |
| K131615 | POLARIS SPINAL SYSTEM | OSH | Substantially Equivalent | |
| K123549 | POLARIS SPINAL SYSTEM - BALLISTA II PERCUTANEOUS SCREW PLACEMENT SYSTEM | NKB | Substantially Equivalent | |
| K123451 | POLARIS SPINAL SYSTEM - BALLISTA II RODS | NKB | Substantially Equivalent | |
| K122989 | BIOMET LATERAL SPACER SYSTEM | MAX | Substantially Equivalent | |
| K122378 | NEXTGEN ALTIUS OCT SYSTEM | KWP | Substantially Equivalent | |
| K113593 | NEXTGEN ALTIUS OCT SYSTEM | KWP | Substantially Equivalent | |
| K110650 | ZYSTON ARC INTERBODY SPACER | MAX | Substantially Equivalent | |
| K100805 | GALLERY LAMINOPLASTY FIXATION SYSTEM | NQW | Substantially Equivalent | |
| K100409 | POLARIS SPINAL SYSTEM, POLARIS/SYNERGY STRUCTUE ANTERIOR FIXATION SYSTEM | NKB | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- KWPAppliance, Fixation, Spinal Interlaminal
- KWQAppliance, Fixation, Spinal Intervertebral Body
- MAXIntervertebral Fusion Device With Bone Graft, Lumbar
- PDQNeurosurgical Nerve Locator
- NQWOrthosis, Spine, Plate, Laminoplasty, Metal
- OSHPedicle Screw Spinal System, Adolescent Idiopathic Scoliosis
- FMFSyringe, Piston
- NKBThoracolumbosacral Pedicle Screw System
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain