Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Integra LifeSciences Corporation · Predicate Candidate Screening
65 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
85 daysmedian FDA review time
262 days90th percentile
65clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251162 | CUSA® Clarity Ultrasonic Surgical Aspirator System | Integra LifeSciences Corporation | 2025-10-08 | 176 | 0 |
| K250752 | AURORA® Surgiscope® System (ASX15/60); AURORA® Surgiscope® S | Integra LifeSciences Corporation | 2025-04-09 | 28 | 0 |
| K240493 | CUSA® Clarity Ultrasonic Surgical Aspirator System | Integra LifeSciences Corporation | 2024-07-11 | 142 | 0 |
| K230427 | CUSA Clarity Ultrasonic Surgical Aspirator System | Integra LifeSciences Corporation | 2023-07-11 | 144 | 0 |
| K221835 | CUSA Clarity Ultrasonic Surgical Aspirator System | Integra LifeSciences Corporation | 2022-08-22 | 60 | 0 |
| K221763 | CUSA Clarity Ultrasonic Surgical Aspirator System | Integra LifeSciences Corporation | 2022-07-15 | 28 | 0 |
| K210128 | INTEGRA Wound Matrix (Macro-Channels) | Integra LifeSciences Corporation | 2021-10-08 | 262 | 0 |
| K210016 | Integra DigiFuse Cannulated Intramedullary Fusion System,Int | Integra LifeSciences Corporation | 2021-07-27 | 204 | 0 |
| K193346 | Codman Surgical Patties & Strips | Integra LifeSciences Corporation | 2020-11-20 | 353 | 23 |
| K201507 | Cadence Total Ankle System | Integra LifeSciences Corporation | 2020-06-29 | 24 | 0 |
| K200774 | CUSA Clarity Ultrasonic Surgical Aspirator System | Integra LifeSciences Corporation | 2020-06-23 | 90 | 0 |
| K190588 | Integra TITAN Reverse Shoulder System | Integra LifeSciences Corporation | 2019-12-02 | 270 | 0 |
| K191684 | MoniTorr ICP External Drainage and Monitoring System, LimiTo | Integra LifeSciences Corporation | 2019-10-11 | 109 | 0 |
| K190180 | CUSA Clarity Ultrasonic Surgical Aspirator System | Integra LifeSciences Corporation | 2019-04-01 | 59 | 0 |
| K182809 | CUSA Clarity Ultrasonic Surgical Aspirator System | Integra LifeSciences Corporation | 2018-12-07 | 65 | 0 |
| K182801 | Codman Electrosurgical Irrigator, Codman Electrosurgical Irr | Integra LifeSciences Corporation | 2018-11-27 | 56 | 0 |
| K181639 | Panta 2 Arthrodesis Nail System | Integra LifeSciences Corporation | 2018-11-02 | 134 | 0 |
| K181999 | Integra TITAN Reverse Shoulder System | Integra LifeSciences Corporation | 2018-10-12 | 78 | 0 |
| K173717 | Integra TITAN Reverse Shoulder System | Integra LifeSciences Corporation | 2018-06-21 | 198 | 0 |
| K172595 | CUSA Excel+ Ultrasonic Surgical Aspirator System | Integra LifeSciences Corporation | 2017-09-28 | 30 | 0 |
| K163456 | DuraGen Secure Dural Regeneration Matrix | Integra LifeSciences Corporation | 2017-01-06 | 28 | 0 |
| K163457 | NeuraGen 3D Nerve Guide Matrix | Integra LifeSciences Corporation | 2017-01-06 | 28 | 0 |
| K160811 | CRW STEREOTACTIC SYSTEM | Integra LifeSciences Corporation | 2016-12-06 | 257 | 0 |
| K161882 | CUSA Clarity Ultrasonic Surgical Aspirator System | Integra LifeSciences Corporation | 2016-10-14 | 95 | 1 |
| K161992 | Horizontal-Vertical Lumbar Valve Systems, Spetzler Lumbar Pe | Integra LifeSciences Corporation | 2016-09-22 | 65 | 0 |
| K161189 | Integra TITAN Reverse Shoulder System | Integra LifeSciences Corporation | 2016-08-25 | 120 | 0 |
| K153041 | Bundled Neurological Shunts and Accessories Product Families | Integra LifeSciences Corporation | 2016-03-14 | 147 | 0 |
| K152897 | Integra DP Valve Systems (including Burr Hole Reservoirs and | Integra LifeSciences Corporation | 2016-03-04 | 155 | 0 |
| K140722 | INTEGRA FLOW REGULATING VALVE SYSTEMS OSV II MODELS AND INTE | Integra LifeSciences Corporation | 2015-01-06 | 291 | 0 |
| K142238 | MAYFIELD Skull Clamp | Integra LifeSciences Corporation | 2014-11-24 | 103 | 0 |
| K141668 | CUSA EXCEL+ ULTRASONIC SURGICAL ASPIRATOR SYSTEM | Integra LifeSciences Corporation | 2014-11-06 | 136 | 0 |
| K141674 | CUSA EXCEL+ ULTRASONIC SURGICAL ASPIRATOR SYSTEM | Integra LifeSciences Corporation | 2014-11-06 | 136 | 1 |
| K142414 | Miltex N-Tralig Intraligamentary Syringe | Integra LifeSciences Corporation | 2014-10-30 | 63 | 0 |
| K130557 | NEURAGEN 3D | Integra LifeSciences Corporation | 2014-04-24 | 416 | 0 |
| K134047 | JARIT GYNECOLOGICAL FORCEPS, MILTEX GYNECOLOGICAL FORCEPS, M | Integra LifeSciences Corporation | 2014-04-11 | 101 | 0 |
| K132250 | INTEGRA FREEDOM WRIST ARTHROPLASTY SYSTEM | Integra LifeSciences Corporation | 2014-03-24 | 248 | 0 |
| K133754 | INTEGRA CAMINO FLEX VENTRICULAR INTRACRANIAL PRESSURE MONITO | Integra LifeSciences Corporation | 2014-03-06 | 87 | 0 |
| K131446 | INTEGRA JARIT HEPARIN CANNULAS, INJECTORS, AND NEEDLES | Integra LifeSciences Corporation | 2013-10-28 | 161 | 0 |
| K130389 | MAYFIELD INFINITY XR2 SKULL CLAMP | Integra LifeSciences Corporation | 2013-04-23 | 67 | 0 |
| K123000 | INTEGRA TOTAL FOOT SYSTEMS | Integra LifeSciences Corporation | 2012-12-21 | 85 | 0 |
| K120012 | INTEGRA JARIT VIDEO ASSISTED THORACIC SURGERY INSTRUMENTS | Integra LifeSciences Corporation | 2012-09-11 | 252 | 0 |
| K120633 | MAYFIELD SKULL CLAMP | Integra LifeSciences Corporation | 2012-05-24 | 84 | 2 |
| K113104 | INTEGRA WOUND MATRIX (THIN) | Integra LifeSciences Corporation | 2012-02-09 | 112 | 0 |
| K103726 | JARIT TAKE-APART ENDOSCOPIC INSTRUMENTS | Integra LifeSciences Corporation | 2012-02-08 | 413 | 1 |
| K101381 | HORIZONTAL-VERTICAL LUMBAR VALVE AND SPETZLER LUMBAR PERITON | Integra LifeSciences Corporation | 2011-07-07 | 416 | 0 |
| K110528 | INTEGRA LED SURGICAL HEADLIGHT SYSTEM | Integra LifeSciences Corporation | 2011-05-11 | 76 | 0 |
| K102875 | CAMINO 110-4B OLM INTRACRANIAL PRESSURE MNITORING KIT; CAMIN | Integra LifeSciences Corporation | 2010-12-20 | 80 | 3 |
| K102802 | INTEGRA ELECTRODE TUNNELING NEEDLE | Integra LifeSciences Corporation | 2010-11-23 | 57 | 0 |
| K093968 | OSV II LOW FLOW LOW PRO VALVE | Integra LifeSciences Corporation | 2010-01-22 | 30 | 0 |
| K092388 | DURAGEN PLUS DURAL REGENERATION MATRIX- SPINAL MATRIX, MODEL | Integra LifeSciences Corporation | 2010-01-21 | 169 | 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