Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Synvasive Technology, Inc. — Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
275 daysmedian FDA review time
549 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K093046 | ELIBRA UNI SOFT-TISSUE FORCE SENSOR, MODEL 61-XXXX(5 MODELS, | Synvasive Technology, Inc. | 2011-03-22 | 538 | 0 |
| K070108 | ELIBRA DYNAMIC KNEE BALANCER | Synvasive Technology, Inc. | 2007-04-04 | 83 | 0 |
| K972508 | SURGICAL BURS AND SURGICAL DRILL BITS | Synvasive Technology, Inc. | 1997-08-26 | 54 | 0 |
| K961522 | KIRSCHNER WIRE (K-WIRE) AND STEINMANN PIN | Synvasive Technology, Inc. | 1996-09-23 | 154 | 0 |
| K950009 | POWERGRIP(TM) COMPRESSION FIXATION DEVICE | Synvasive Technology, Inc. | 1995-08-18 | 227 | 0 |
| K934336 | SPINALPLANE | Synvasive Technology, Inc. | 1995-03-10 | 549 | 0 |
| K933933 | CEBOPLANE | Synvasive Technology, Inc. | 1994-04-15 | 247 | 0 |
| K930573 | SYNVASIVE CERAMIC SUTTING BLOCK | Synvasive Technology, Inc. | 1994-04-07 | 427 | 0 |
| K932869 | ARTHROPLANE | Synvasive Technology, Inc. | 1994-03-25 | 284 | 0 |
| K931737 | HEDLEYL INTRAMEDULLARY PREPARATION BRUSH | Synvasive Technology, Inc. | 1994-01-07 | 275 | 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