Data / Medical devices / Netherlands / ARVATO Netherlands B.V.
ARVATO Netherlands B.V.: FDA-registered device maker in Heijen Limburg, Netherlands, 62 510(k) clearances
ARVATO Netherlands B.V. is registered with the FDA (registration 3013302242) in Heijen Limburg, Netherlands. It lists 36 device types. The FDA files 62 510(k) clearances under its listings, the newest dated October 31, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013302242
- Address
- Brem 1, Heijen Limburg, Netherlands, 6598
- Owner or operator
- Arvato Netherlands B.V. (10077655)
- Roles
- Exporter to the US
- First device listed
- September 10, 2020
- Registered through
- 2026
- Brand names listed
- Hallu Lock plate system, Newdeal, Newdeal Compression Plates, Panta XL, Smith & Nephew, Inc., Stabilization Screw, TIBIAXYS SYSTEM
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 31, 2019 | K191002 | OR3O Dual Mobility System | LPH | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| January 24, 2019 | K183346 | FLOW 90 Wand | GEI | Substantially Equivalent | ArthroCare Corporation | accessdata.fda.gov |
| May 1, 2018 | K180848 | AMBIENT Super MULTIVAC 50 Wand with Integrated Finger Switches | GEI | Substantially Equivalent | ArthroCare Corporation | accessdata.fda.gov |
| November 30, 2017 | K171934 | Birmingham Hip (BH) Dual Mobility Insert | LPH | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| August 17, 2017 | K172165 | Q-Fix Suture Anchor | MBI | Substantially Equivalent | ArthroCare Corporation | accessdata.fda.gov |
| October 21, 2016 | K161481 | Ambient HipVac 50 Wand with Integrated Finger Switches | GEI | Substantially Equivalent | ArthroCare Corporation | accessdata.fda.gov |
| January 28, 2016 | K153186 | Adjustable Fixation Device | MBI | Substantially Equivalent | Arthrocare Corp. | accessdata.fda.gov |
| October 23, 2015 | K143235 | RF20000a Controller, FLOW 50 Wand | GEI | Substantially Equivalent | ArthroCare Corporation | accessdata.fda.gov |
| April 20, 2015 | K143739 | POLARSTEM Collared (Standard and Lateral) and Valgus Femoral Stem with Ti/HA | LZO | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| June 10, 2014 | K140521 | TOPAZ EZ MICRODEBRIDER COBLATION WAND WITH INTEGRATED FINGER SWITCH | GEI | Substantially Equivalent | ArthroCare Corporation | accessdata.fda.gov |
| January 16, 2014 | K133727 | Q-FIX SUTURE ANCHOR, 1.8MM; Q-FIX SUTURE ANCHOR, 2.8MM; DRILL, DRILL GUIDE AND OBTURATOR, 1.8MM & 2.8MM, FIRSTPASS SUTU | MBI | Substantially Equivalent | ArthroCare Corporation | accessdata.fda.gov |
| October 22, 2013 | K132435 | SMITH & NEPHEW GLOBAL FEMORAL HEAD TRIALS | LZO | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| October 10, 2013 | K130728 | POLARSTEM STANDARD AND LATERAL FEMORAL STEMS WITH TI/HA | LZO | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| July 2, 2013 | K122652 | ARTHROCARE TURBINATOR WAND | GEI | Substantially Equivalent | ArthroCare Corporation | accessdata.fda.gov |
| June 28, 2013 | K123598 | SMITH & NEPHEW, INC. HIP SYSTEM INSTRUMENTATION | JDI | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| February 27, 2013 | K130196 | SPEEDLOCK KNOTLESS FIXATION DEVICE, 3MM DRILL, 3MM+ DRILL, PATHFINDER OBTURATOR & SHARP TIPPED OBTURATOR, LOW PROFILE DR | MBI | Substantially Equivalent | Arthrocare Corp. | accessdata.fda.gov |
| February 14, 2013 | K123240 | SPEEDLOCK HIP KNOTLESS FIXATION IMPLANT | MBI | Substantially Equivalent | ArthroCare Corporation | accessdata.fda.gov |
| November 15, 2012 | K122011 | NAVIGATION SOFTWARE HIP-UNIVERSAL; NAVIGATION SOFTWARE HIP THR-AESCULAP | OLO | Substantially Equivalent | Brainlab AG | accessdata.fda.gov |
| November 7, 2012 | K123268 | SMARTSTITCH PERFECTPASSER SYSTEM | GAT | Substantially Equivalent | Arthocare Corporation | accessdata.fda.gov |
| August 28, 2012 | K122296 | SL-PLUS MIA FEMORAL STEMS WITH TI/HA COATING | LZO | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| August 23, 2012 | K122244 | POLARCUP DUAL MOBILITY SYSTEM | LPH | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| August 13, 2012 | K121443 | JOURNEY II CR KNEE SYSTEM | JWH | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| July 19, 2012 | K120211 | SL-PLUS STANDARD AND LATERAL FEMORAL STEM WITH TI/HA COATING | LZO | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| January 5, 2012 | K113038 | SMITH & NEPHEW INC. UNICOMPARTMENTAL AND BIOCOMPARTMENTAL KNEE SYSTEM INSTRUMENTS | HSX | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| October 14, 2011 | K110135 | POLARCUP DUAL MOBILITY SYSTEM | LPH | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| September 16, 2011 | K111711 | JOURNEY II BCS KNEE SYSTEM | JWH | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| April 4, 2011 | K102990 | BRAINLAB KNEE | OLO | Substantially Equivalent | Brainlab AG | accessdata.fda.gov |
| May 13, 2010 | K100353 | SPINEWAND SURGICAL DEVICE | GEI | Substantially Equivalent | Arthrocare Corp. | accessdata.fda.gov |
| May 6, 2010 | K092467 | VECTORVISION CRANIAL, VECTORVISION ENT, KOLIBRI CRANIAL, KOLIBRI ENT, CRANIAL ESSENTIAL, CRANIAL UNLIMITED | HAW | Substantially Equivalent | Brainlab AG | accessdata.fda.gov |
| July 29, 2009 | K091788 | PANTA NAIL (DIA. 10MM), PANTA NAIL XL | HSB | Substantially Equivalent | Newdeal Sas | accessdata.fda.gov |
| July 10, 2009 | K083154 | NEWDEAL HALLU LOCK PLATE SYSTEM | HRS | Substantially Equivalent | Newdeal Sas | accessdata.fda.gov |
| April 8, 2009 | K083483 | BRAINLAB HIP UNLIMITED, CI HIP UNLIMITED | OLO | Substantially Equivalent | Brainlab AG | accessdata.fda.gov |
| December 10, 2008 | K083306 | MODIFICATION TO ARTHROCARE ARTHROWANDS | GEI | Substantially Equivalent | Arthrocare Corp. | accessdata.fda.gov |
| September 5, 2008 | K081016 | SMITH & NEPHEW, INC., PROMOS REVERSE SHOULDER SYSTEM | PHX | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| June 9, 2008 | K072852 | SL-PLUS STANDARD AND LATERAL HIP STEMS | LZO | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| March 20, 2008 | K080482 | ARTHROCARE IRRIGATION PUMP, MODEL SIP001-00, SIP001-01 | GEI | Substantially Equivalent | Arthrocare Corp. | accessdata.fda.gov |
| February 21, 2008 | K073375 | NEWDEAL TIBIAXYS SYSTEM | HRS | Substantially Equivalent | Newdeal Sas | accessdata.fda.gov |
| February 15, 2008 | K080282 | ARTHROCARE CONTROLLERS (SYSTEM 2000,1100,1200), MODEL H2076-00, H2079-00, H3000-00, H4000-00; | GEI | Substantially Equivalent | Arthrocare Corp. | accessdata.fda.gov |
| November 20, 2007 | K072858 | TC-PLUS PRIMARY KNEE SYSTEM | JWH | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| November 19, 2007 | K072818 | PERI-LOC PERIARTRICULAR LCK PIT SYS-PROX FEM PLATES/SCREWS.CALBE ACCESS | HRS | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| April 25, 2007 | K070374 | ARTHROCARE ENT PLASMA WAND | GEI | Substantially Equivalent | Arthrocare Corp. | accessdata.fda.gov |
| April 23, 2007 | K070106 | VV FLUORO 3D | HAW | Substantially Equivalent | Brainlab AG | accessdata.fda.gov |
| April 16, 2007 | K070278 | POLARCUP DUAL MOBILITY SYSTEM | LPH | Substantially Equivalent | Plus Orthopedics AG | accessdata.fda.gov |
| April 2, 2007 | K070673 | FORCE FIBER BLACK CO-BRAID POLYETHYLENE NON-ABSORBABLE SURGICAL SUTURE | GAT | Substantially Equivalent | Teleflexmedical, Inc. | accessdata.fda.gov |
| March 29, 2007 | K070447 | NEWDEAL COMPRESSION PLATE | HRS | Substantially Equivalent | Newdeal Sas | accessdata.fda.gov |
| March 2, 2007 | K063578 | PROMOS MODULAR SHOULDER SYSTEM | HSD | Substantially Equivalent | Plus Orthopedics AG | accessdata.fda.gov |
| April 18, 2006 | K060736 | SMITH & NEPHEW 6.5MM AND 8.0MM CANNULATED SCREWS | HWC | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| March 17, 2005 | K050346 | STABILIZATION SCREW | HWC | Substantially Equivalent | New Deal, S.A. | accessdata.fda.gov |
| December 14, 2004 | K042584 | OPUS MINIMAGNUM ANCHOR WITH INSERTER | HWC | Substantially Equivalent | Opus Medical, Inc. | accessdata.fda.gov |
| November 12, 2004 | K042914 | OPUS MAGNUM KNOTLESS ANCHOR WITH INSERTER HANDLE | MBI | Substantially Equivalent | Opus Medical, Inc. | accessdata.fda.gov |
| October 19, 2004 | K042031 | OPUS SPEEDSTITCH SUTURE DEVICE | GAT | Substantially Equivalent | Opus Medical, Inc. | accessdata.fda.gov |
| February 20, 2004 | K040212 | TRIGEN INTERTAN | JDS | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| January 8, 2004 | K032126 | PROMOS SHOULDER | HSD | Substantially Equivalent | Plus Orthopedics | accessdata.fda.gov |
| December 10, 2003 | K033669 | SMITH & NEPHEW LOCKING BONE PLATE SYSTEM (LOCKING BONE PLATES AND SCREWS) | HRS | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| November 28, 2003 | K033584 | ARTHROCARE ARTHROWANDS | GEI | Substantially Equivalent | Arthrocare Corp. | accessdata.fda.gov |
| January 23, 2003 | K023743 | SMITH & NEPHEW GLOBAL BIPOLAR SYSTEM | KWY | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| December 15, 2000 | K002747 | REFLECTION CROSS-LINKED UHMWPE ACETABULAR COMPONENTS | LPH | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| October 13, 2000 | K000666 | TC-PLUS SOLUTION KNEE | JWH | Substantially Equivalent | Plus Orthopedics | accessdata.fda.gov |
| December 20, 1999 | K993289 | SMITH & NEPHEW COMPRESSION HIP SCREW SYSTEM, INTRAMEDULLARY HIP SCREW SYSTEM | KTT | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| October 31, 1995 | K954712 | INTRAMEDULLARY HIP SCREW (MODIFICATION) | KTT | Substantially Equivalent | Smith & Nephew Richards, Inc. | accessdata.fda.gov |
| August 22, 1995 | K951987 | GENESIS II TOTAL KNEE SYSTEM | JWH | Substantially Equivalent | Smith & Nephew Richards, Inc. | accessdata.fda.gov |
| February 22, 1994 | K933027 | THE MODULAR NAIL | HSB | Substantially Equivalent | Smith & Nephew Richards, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Orthopedic Stereotaxic Instrument
- All makers of Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
- All makers of Suture, Nonabsorbable, Synthetic, Polyethylene
- All makers of Accessories, Arthroscopic
- All makers of Plate, Fixation, Bone
- All makers of Screw, Fixation, Bone
Updated October 31, 2019. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.