Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Integrity Implants, Inc. — Predicate Candidate Screening

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

126 daysmedian FDA review time
170 days90th percentile
11clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K231098LineSider® Spinal SystemIntegrity Implants, Inc.2023-08-071110
K213355Toro-L Interbody Fusion SystemIntegrity Implants, Inc.2022-03-251640
K220453FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.2022-03-24350
K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc.2021-12-231700
K203038Toro-L Interbody Fusion SystemIntegrity Implants, Inc.2021-03-261710
K203367LineSider™ Spinal SystemIntegrity Implants, Inc.2020-12-03174
K202198FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.2020-11-03900
K201367FlareHawk TiHawk9 Interbody Fusion SystemIntegrity Implants, Inc.2020-09-231240
K190360LineSider™ Spinal SystemIntegrity Implants, Inc.2019-06-211260
K183184FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.2019-04-031350
K182114FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.2019-01-071540

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