Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Seaspine, Inc. — Predicate Candidate Screening
27 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
94 daysmedian FDA review time
239 days90th percentile
27clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K231654 | NorthStar OCT System | Seaspine, Inc. | 2023-08-03 | 58 | 0 |
| K150469 | Integra Laminoplasty System | Seaspine, Inc. | 2015-03-23 | 28 | 0 |
| K142488 | SeaSpine Spacer System - (Hollywood, Pacifica, Redondo, Vent | Seaspine, Inc. | 2014-12-18 | 105 | 0 |
| K133418 | INTEGRA EXPANDABLE INTERVEREBRAL BODY FUSION DEVICE (IBD) SY | Seaspine, Inc. | 2014-05-01 | 175 | 0 |
| K132859 | INTEGRA FACET FIXATION SYSTEM | Seaspine, Inc. | 2013-11-18 | 67 | 0 |
| K121924 | INTEGRA INTERSPINOUS PROCESS SYSTEM | Seaspine, Inc. | 2013-09-04 | 429 | 0 |
| K130830 | INTEGRA LAMINOPLASTY SYSTEM | Seaspine, Inc. | 2013-05-09 | 44 | 0 |
| K122571 | MALIBU SPINAL SYSTEM WITH THE DAYTONA DEFORMITY SYSTEM | Seaspine, Inc. | 2012-12-12 | 111 | 0 |
| K112206 | CARDIFF ANTERIOR CERVICAL PLATE SYSTEM | Seaspine, Inc. | 2012-01-25 | 177 | 0 |
| K111671 | SEASPINE MONOPOLAR PROBE SYSYEM | Seaspine, Inc. | 2011-12-28 | 196 | 0 |
| K102026 | SEASPINE SPACER SYSTEM | Seaspine, Inc. | 2011-05-12 | 297 | 0 |
| K103297 | REDONDO-L | Seaspine, Inc. | 2011-01-27 | 80 | 0 |
| K092521 | ZUMA-C | Seaspine, Inc. | 2010-04-13 | 238 | 0 |
| K082309 | CAMBRIA | Seaspine, Inc. | 2009-04-09 | 239 | 0 |
| K083338 | CARDIFF ANTERIOR CERVICAL PLATE SYSTEM | Seaspine, Inc. | 2009-02-02 | 82 | 0 |
| K083089 | NEWPORT SPINAL SYSTEM | Seaspine, Inc. | 2009-01-13 | 89 | 2 |
| K082926 | ZUMA, MODEL 55-XXXX/56-XXXX | Seaspine, Inc. | 2008-12-22 | 82 | 0 |
| K082310 | HOLLYWOOD, PACIFICA, REDONDO, VENTURA | Seaspine, Inc. | 2008-11-10 | 89 | 0 |
| K072729 | SIERRA | Seaspine, Inc. | 2008-04-17 | 204 | 0 |
| K080526 | SIERRA SYSTEM | Seaspine, Inc. | 2008-04-16 | 50 | 0 |
| K072605 | MALIBU SPINAL SYSTEM | Seaspine, Inc. | 2007-12-20 | 94 | 0 |
| K071726 | ZUMA | Seaspine, Inc. | 2007-10-23 | 120 | 0 |
| K062934 | SIERRA | Seaspine, Inc. | 2006-11-16 | 49 | 0 |
| K061342 | MALIBU SPINAL SYSTEM | Seaspine, Inc. | 2006-10-25 | 193 | 1 |
| K052170 | SEASPINE VBR SYSTEM | Seaspine, Inc. | 2005-12-21 | 134 | 0 |
| K051942 | MALIBU SPINAL SYSTEM | Seaspine, Inc. | 2005-07-27 | 12 | 11 |
| K051663 | MALIBU SPINAL SYSTEM | Seaspine, Inc. | 2005-07-12 | 20 | 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