Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Integra Lifesciences Corp. — Predicate Candidate Screening
29 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
75 daysmedian FDA review time
276 days90th percentile
29clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K183581 | Codman Disposable Perforators | Integra Lifesciences Corp. | 2019-01-20 | 30 | 3 |
| K183406 | CereLink ICP Monitor, CereLink ICP Extension Cable | Integra Lifesciences Corp. | 2019-01-11 | 32 | 0 |
| K182265 | CodMan Certas Plus Programmable Valve | Integra Lifesciences Corp. | 2018-11-20 | 91 | 0 |
| K181902 | Codman Certas Plus Electronic Tool Kit | Integra Lifesciences Corp. | 2018-10-25 | 101 | 0 |
| K150682 | CUSA Excel+ | Integra Lifesciences Corp. | 2015-12-18 | 276 | 0 |
| K150428 | Integra (R) Jarit (R) Kerrison Rongeurs, Integra (R) Ruggles | Integra Lifesciences Corp. | 2015-04-16 | 56 | 0 |
| K131184 | INTEGRA LICOX PTO2 MONITOR | Integra Lifesciences Corp. | 2013-08-30 | 127 | 5 |
| K092227 | JARIT, RUGGLES, R&B REDMOND/ REDMOND, MILTEX, MEISTERHAND - | Integra Lifesciences Corp. | 2010-02-17 | 209 | 0 |
| K092395 | OSV II LUMBAR VALVE SYSTEM AND OSV II LOW FLOW LUMBAR VALVE | Integra Lifesciences Corp. | 2009-11-19 | 106 | 0 |
| K081635 | INTEGRA MESHED BILAYER WOUND MATRIX | Integra Lifesciences Corp. | 2008-12-04 | 176 | 0 |
| K081401 | MAYFIELD MR/X-RAY SKULL CLAMP | Integra Lifesciences Corp. | 2008-10-08 | 142 | 0 |
| K072113 | INTEGRA FLOWABLE WOUND MATRIX, MODEL FWD301 | Integra Lifesciences Corp. | 2007-10-10 | 70 | 0 |
| K072207 | DURAGEN XS DURAL REGENERATION MATRIX | Integra Lifesciences Corp. | 2007-08-23 | 15 | 6 |
| K063124 | INTEGRA MOZAIK BONE REGENERATION MATRIX - STRIPS | Integra Lifesciences Corp. | 2007-01-19 | 98 | 1 |
| K053244 | LICOX IT2 COMPLETE BRAIN TUNNELING PROBE KIT | Integra Lifesciences Corp. | 2006-05-10 | 170 | 1 |
| K051440 | MAYFIELD INFINITY SKULL CLAMP | Integra Lifesciences Corp. | 2005-09-20 | 110 | 0 |
| K050319 | MAYFIELD MR/CT SKULL CLAMP, MODEL 4-0-A-1104 | Integra Lifesciences Corp. | 2005-03-31 | 50 | 0 |
| K050492 | INTEGRA BONE FIXATION SYSTEM | Integra Lifesciences Corp. | 2005-03-14 | 14 | 0 |
| K043427 | DURAGEN II DURAL REGENERATION MATRIX | Integra Lifesciences Corp. | 2005-01-12 | 30 | 2 |
| K041620 | NEURA WRAP NERVE PROTECTOR | Integra Lifesciences Corp. | 2004-07-16 | 30 | 1 |
| K032693 | DURAGEN PLUS DURAL GRAFT MATRIX | Integra Lifesciences Corp. | 2003-09-30 | 28 | 1 |
| K030289 | HERMETIC PLUS EXTERNAL CSF DRAINAGE SYSTEMS, INS-8301,INS-83 | Integra Lifesciences Corp. | 2003-02-26 | 29 | 0 |
| K022127 | AVAGEN WOUND DRESSING | Integra Lifesciences Corp. | 2002-09-10 | 71 | 0 |
| K021792 | BILAYER MATRIX WOUND DRESSING | Integra Lifesciences Corp. | 2002-08-14 | 75 | 1 |
| K003229 | BIOPATCH ANTIMICROBIAL DRESSING | Integra Lifesciences Corp. | 2001-10-26 | 381 | 0 |
| K011168 | NEUROGEN NERVE GUIDE | Integra Lifesciences Corp. | 2001-06-22 | 66 | 1 |
| K992216 | BIOMEND EXTEND ABSORBABLE COLLAGEN MEMBRANE, BIOMEND ABSORBA | Integra Lifesciences Corp. | 1999-07-26 | 25 | 1 |
| K982180 | DURAGEN DURAL GRAFT MATRIX | Integra Lifesciences Corp. | 1999-07-06 | 379 | 1 |
| K990086 | HELIDERM COLLAGEN WOUND DRESSINGS 0.5 GRAM AND 1.0 GRAM | Integra Lifesciences Corp. | 1999-03-31 | 79 | 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