FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K040080 |
AESCULAP, INC. |
AESCULAP ABSORBABLE CRANIOFIX |
03/31/2004 |
K091692 |
AESCULAP, INC. |
AESCULAP PEEK CRANIOFIX |
08/12/2010 |
K130309 |
BIOMET MICROFIXATION |
RAPIDFLAP LS CRANIAL FLAP FIXATION SYSTEM |
06/17/2013 |
K001096 |
IMAGE-GUIDED NEUROLOGICS, INC. |
BURR HOLE COVER, MODEL XX |
10/25/2000 |
K002334 |
MACROPORE BIOSURGERY, INC. |
MACROPORENS CRANILOC |
05/02/2001 |
K010361 |
MEDTRONIC PS MEDICAL |
MEDTRONIC PS MEDICAL INVISX CRANIAL FIXATION SYSTEM, MODEL 60100-60900 |
05/07/2001 |
K160739 |
Neos Surgery S.L. |
Cranial COVER |
06/12/2016 |
K101235 |
NEOS SURGERY S.L. |
CRANIAL LOOP CRANIAL BONE FIXATION SYSTEM |
10/25/2010 |
K132044 |
NEOS SURGERY S.L. |
CRANIAL LOOP, CRANIAL LOOP L AND CRANIAL LOOP XL AND CRANIAL BONE FIXATION SYSTEM |
09/30/2013 |
K141368 |
NEUROPACE INC |
NEUROPACE BURR HOLE COVER |
07/11/2014 |
K123163 |
NEUROPACE INC |
NEUROPACE BURR HOLE COVER MODEL 8110 |
01/18/2013 |
K192162 |
NeuroVention LLC |
NeuroVention Cranial Fixation System, NuCrani Plates, KTC Burr Hole Cover, DC Plate |
03/13/2020 |
K192310 |
Ossaware Biotech Co., Ltd. |
Flap Fixator, Burr Hole Cover |
06/03/2020 |
K140309 |
OSSDSIGN AB |
CRANIOPLUG |
10/03/2014 |
K181539 |
OssDsign AB |
OSSDSIGN Cranioplug |
10/12/2018 |
K071138 |
PROSURG, INC. |
CRANIOCLAMP BIOABSORBABLE CRANIAL BONE FLAP FIXATION SYSTEM |
08/15/2007 |
K181382 |
St Jude Medical |
GuardianTM Burr Hole Cover System |
07/20/2018 |
K152342 |
ST. JUDE MEDICAL |
Guardian Burr Hole Cover System, Guardian Screw, Burr Hole Cover |
06/09/2016 |
K042986 |
SYNTHES (USA) |
MODIFICATION TO SYNTHES (USA) (SYNTHES) LOW PROFILE NEURO SYSTEM |
11/17/2004 |
K021408 |
SYNTHES (USA) |
RESORBABLE CRANIAL CLAMPS |
07/29/2002 |
K041611 |
SYNTHES (USA) |
SYNTHES (USA) RAPID RESORBABLE CRANIAL CLAMP |
09/08/2004 |
K031654 |
SYNTHES (USA) |
SYNTHES RESORBABLE CRANIAL CLAMP, (MODIFIED) |
08/08/2003 |
K123633 |
TISSUE REGENERATION SYSTEMS, INC. |
TRS CRANIAL BONE VOID FILLER(TRS C-BVF) |
08/16/2013 |
K960656 |
W.L. GORE & ASSOCIATES,INC |
GORE BURR HOLE COVER |
08/14/1996 |