Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Biomet Spine (Aka Ebi, LLC) · Predicate Candidate Screening
13 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
118 daysmedian FDA review time
240 days90th percentile
13clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K133518 | MAXAN ANTERIOR CERVICAL PLATE SYSTEM | Biomet Spine (Aka Ebi, LLC) | 2014-11-05 | 355 | 1 |
| K140710 | BIOMET GRAFT DELIVERY SYRINGES | Biomet Spine (Aka Ebi, LLC) | 2014-09-04 | 167 | 0 |
| K132373 | BIOMET ACCESS SYSTEM | Biomet Spine (Aka Ebi, LLC) | 2014-03-27 | 240 | 0 |
| K133746 | POLARIS SPINAL SYSTEM | Biomet Spine (Aka Ebi, LLC) | 2014-03-12 | 93 | 1 |
| K131615 | POLARIS SPINAL SYSTEM | Biomet Spine (Aka Ebi, LLC) | 2013-09-04 | 93 | 0 |
| K123549 | POLARIS SPINAL SYSTEM - BALLISTA II PERCUTANEOUS SCREW PLACE | Biomet Spine (Aka Ebi, LLC) | 2013-02-25 | 98 | 2 |
| K123451 | POLARIS SPINAL SYSTEM - BALLISTA II RODS | Biomet Spine (Aka Ebi, LLC) | 2012-12-03 | 24 | 0 |
| K122989 | BIOMET LATERAL SPACER SYSTEM | Biomet Spine (Aka Ebi, LLC) | 2012-10-24 | 28 | 0 |
| K122378 | NEXTGEN ALTIUS OCT SYSTEM | Biomet Spine (Aka Ebi, LLC) | 2012-09-20 | 45 | 1 |
| K113593 | NEXTGEN ALTIUS OCT SYSTEM | Biomet Spine (Aka Ebi, LLC) | 2012-04-17 | 134 | 0 |
| K110650 | ZYSTON ARC INTERBODY SPACER | Biomet Spine (Aka Ebi, LLC) | 2011-06-30 | 118 | 0 |
| K100805 | GALLERY LAMINOPLASTY FIXATION SYSTEM | Biomet Spine (Aka Ebi, LLC) | 2010-07-20 | 120 | 0 |
| K100409 | POLARIS SPINAL SYSTEM, POLARIS/SYNERGY STRUCTUE ANTERIOR FIX | Biomet Spine (Aka Ebi, LLC) | 2010-06-23 | 127 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda