Atlas FDA

Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Zavation Medical Products, LLC · Predicate Candidate Screening

31 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

93 daysmedian FDA review time
218 days90th percentile
31clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K253943Tiger 2 SystemZavation Medical Products, LLC2026-07-242260
K243908Tiger 2 SystemZavation Medical Products, LLC2025-02-03460
K233509Zavation IBF System, Zavation Varisync Plate System and VariZavation Medical Products, LLC2024-04-101620
K231811Zavation Connector SystemZavation Medical Products, LLC2023-08-22620
K223808Zavation Navigation Instrument SystemZavation Medical Products, LLC2023-07-122040
K230731Zavation ALIF SystemZavation Medical Products, LLC2023-06-14900
K221726Uni-FuZe-C Bone StripZavation Medical Products, LLC2023-01-182180
K222614Zavation Spinal SystemZavation Medical Products, LLC2022-12-05970
K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC2022-08-121230
K220581Zavation eZspand Interbody SystemZavation Medical Products, LLC2022-06-02930
K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC2022-04-122210
K211993Z-LINKPC SystemZavation Medical Products, LLC2021-08-11440
K211113Zavation Spinal SystemZavation Medical Products, LLC2021-07-12890
K211306LABYRINTHZavation Medical Products, LLC2021-06-24560
K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC2021-01-291610
K201781Uni-FuZe-P Bone PuttyZavation Medical Products, LLC2020-12-281810
K202624Z-Span Plate SystemZavation Medical Products, LLC2020-11-04550
K200084Zavation IBF SystemZavation Medical Products, LLC2020-10-192780
K202305Zavation IBF SystemZavation Medical Products, LLC2020-10-13600
K191354Ti3Z Cervical Interbody SystemZavation Medical Products, LLC2019-09-091110
K191339Zavation eZspand Interbody SystemZavation Medical Products, LLC2019-08-19910
K191423Normandy VBR SystemZavation Medical Products, LLC2019-08-06690
K190317Zavation Spinal SystemZavation Medical Products, LLC2019-04-11570
K190361Zavation Spinal SystemZavation Medical Products, LLC2019-03-18310
K180076Ti 3Z Interbody SystemZavation Medical Products, LLC2018-07-271980
K180673Normandy VBR SystemZavation Medical Products, LLC2018-07-131210
K181244Zavation Cervical Plate SystemZavation Medical Products, LLC2018-07-10610
K181246Zavation IBF SystemZavation Medical Products, LLC2018-07-10610
K180537Zavation Buttress Plate SystemZavation Medical Products, LLC2018-03-27270
K173752SI Screw SystemZavation Medical Products, LLC2018-03-16980
K173306EZ PlateZavation Medical Products, LLC2018-01-22960

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