Integra® - CRANIAL ACCESS KIT
2016-09-16
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 1722447 | 1000138491 | Integra Pain Management | 1 | N | 2026-01-01 | 3498 WEST 2400 SOUTH #1050 West Valley City UT US 84119 |
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 30381780263917 | Integra® - CRANIAL ACCESS KIT | +1(800)654-2873 | custsvcnj@integralife.com |
| 30381780263924 | Integra® - CRANIAL ACCESS KIT | +1(800)654-2873 | custsvcnj@integralife.com |
| 30381780263931 | Integra® - CRANIAL ACCESS KIT | +1(800)654-2873 | custsvcnj@integralife.com |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 75199 | 1276593041 | K993655 | MICRO-FRANCE ELECTROSURGICAL INSTRUMENTS, VARIOUS | GEI | 1999-12-21 |
| 75199 | 1254607734 | K961113 | CNS INTERCHANGEABLE BIT CRANIAL DRILL | HBG | 1996-06-05 |
| 75199 | 2028583999 | K960692 | SUBTALAR MBA SYSTEM | HWC | 1996-07-23 |
| 75199 | 2043936071 | K960248 | GENERAL PROCEDURE KIT | FMF | 1996-04-12 |
| 75199 | 1201408899 | K960100 | SPINAL SPECIALTIES NERVE BLOCK TRAY | CAZ | 1996-04-24 |
| 75199 | 1136422705 | K960082 | DISCOGRAPHY KIT | IZG | 1996-03-21 |
| 75199 | 1758140045 | K950820 | SPINAL SPECIALTIES PENCIL-POINT SPINAL NEEDLE | BSP | 1995-06-30 |
| 75199 | 1936646819 | K945484 | PIDURAL STEROID SYSTEM | CAZ | 1995-06-02 |
| 75199 | 1103965614 | K944463 | CRW-1 SYSTEM | HAW | 1995-10-26 |
| 75199 | 1033582252 | K942863 | EPIDURAL NEEDLE | BSP | 1995-08-11 |
| 75199 | 1583206643 | K941558 | MAYFIELD CHILD DISPOSABLE SKULL PIN | HBL | 1995-12-06 |
| 75199 | 1646538603 | K941343 | SPINAL ANESTHESIA TRAY | CAZ | 1994-08-11 |
| 75199 | 1252136316 | K935245 | EPIDURAL ANESTHESIA TRAY | CAZ | 1994-05-02 |
| 75199 | 1138788708 | K932860 | MAYFIELD ADULT DISPOSABLE SKULL PIN | HBL | 1993-09-28 |
| 75199 | 1282612185 | K924724 | KINETIK GREAT TOE SYSTEM | LZJ | 1994-01-05 |
| 75199 | 1618835943 | K923789 | MAYFIELD ADULT DISPOSABLE SKULL PIN | HBL | 1993-02-12 |
| 75199 | 1277736409 | K862160 | CAMINO HAND DRILL - MODEL 030 | HBG | 1986-07-18 |
| 75199 | 1755722249 | K182809 | CUSA Clarity Ultrasonic Surgical Aspirator System | LFL | 2018-12-07 |
| 75199 | 2016034898 | K161882 | CUSA Clarity Ultrasonic Surgical Aspirator System | LFL | 2016-10-14 |
| 75199 | 1827993708 | K160811 | CRW STEREOTACTIC SYSTEM | HAW | 2016-12-06 |
| 75199 | 1848949964 | K152047 | INTEGRA TITAN Modular Total Shoulder System Fin-Lock Glenoid | KWS | 2015-12-23 |
| 75199 | 1697995180 | K151459 | Integra Total Ankle Replacement System | HSN | 2015-08-31 |
| 75199 | 1892720264 | K141674 | CUSA EXCEL+ ULTRASONIC SURGICAL ASPIRATOR SYSTEM | LFL | 2014-11-06 |
| 75199 | 1011255962 | K132250 | INTEGRA FREEDOM WRIST ARTHROPLASTY SYSTEM | JWJ | 2014-03-24 |
| 75199 | 2048917324 | K130050 | TITAN REVERSE SHOULDER SYSTEM | KWS | 2013-06-18 |
| 75199 | 1776535364 | K102258 | CUSA NXT EXTENDED LENGTH TIP | LFL | 2011-06-10 |
| 75199 | 1247055172 | K093163 | INTEGRA TOTAL WRIST FUSION SYSTEM | HRS | 2009-12-15 |
| 75199 | 1884798462 | K072208 | MAYFIELD DISPOSABLE AND REUSABLE TITANIUM SKULL PINS | HBL | 2007-09-07 |
| 75199 | 1678745075 | K071458 | MAYFIELD RADIOLUCENT DISPOSABLE SKULL PINS | HBL | 2007-06-13 |
| 75199 | 1495659486 | K040356 | KOMPRESSOR SCREW SYSTEM | HWC | 2004-03-01 |
| 75199 | 1814818014 | K032806 | KATALYST RADIAL HEAD IMPLANT | KWI | 2004-04-16 |
| 75199 | 1054803178 | K032054 | RADIONICS NASHOLD BIOPSY NEEDLE - SINGLE USE | HAW | 2003-09-15 |
| 75199 | 1284921748 | K030037 | UNIVERSAL TOTAL WRIST SYSTEM | JWJ | 2003-02-05 |
| 75199 | 1491003544 | K023770 | K2 HEMI TOE IMPLANT SYSTEM (FORMERLY ZOBEL GREAT TOE IMPLANT SYSTEM) | KWD | 2002-12-12 |
| 75199 | 1012811137 | ||||
| 75199 | 1475295102 | ||||
| 75199 | 1499438017 | ||||
| 75199 | 1022877110 | ||||
| 75199 | 1037177068 | ||||
| 75199 | 1105110666 | ||||
| 75199 | 1217450459 | ||||
| 75199 | 1304182435 | ||||
| 75199 | 1345884951 | ||||
| 75199 | 1404019310 | ||||
| 75199 | 1442802373 | ||||
| 75199 | 1446860232 | ||||
| 75199 | 1547442199 | ||||
| 75199 | 1829588122 | ||||
| 75199 | 1981491097 | ||||
| 75199 | 2005141462 |
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