FDA Product Code
FDA Product Code OLO — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Neurology
- 21 CFR Citation
- 882.4560
510(k) Clearances — 441 records · page 5 of 5
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K131130 | NAVIGATION PIN | Evergreen Orthopedic Research Lab | 2013-07-19 | Traditional | PDF ↗ |
| K124004 | NAVIGATED CD HORIZON SOLERA SCREWDRIVERS, TAPS, ILIAC TAPS, LEGACY TAPS | Medtronic Navigation, Inc. | 2013-03-22 | Traditional | PDF ↗ |
| K121765 | SCULPTOR ROBOTIC GUIDANCE ARM (RGA) | Stanmore Implants Worldwide , Ltd. | 2013-01-11 | Traditional | PDF ↗ |
| K122742 | NUVASIVE BENDINI SPINAL ROD BENDING SYSTEM | Nuvasive, Inc. | 2012-12-07 | Special | PDF ↗ |
| K122326 | SMARTTOOLS KNEE SYSTEM | Zimmer | 2012-11-30 | Traditional | PDF ↗ |
| K121936 | NAVIOPFS | Blue Belt Technologies, Inc. | 2012-11-30 | Traditional | PDF ↗ |
| K122011 | NAVIGATION SOFTWARE HIP-UNIVERSAL; NAVIGATION SOFTWARE HIP THR-AESCULAP | Brainlab AG | 2012-11-15 | Traditional | PDF ↗ |
| K120867 | VIPER AND EXPEDIUM NAVIGATED INSTRUMENTS | Medos International SARL | 2012-09-20 | Traditional | PDF ↗ |
| K121064 | MAKOPLASTY TOTAL HIP APPLICATION, RIO STANDARD SYSTEM | Mako Surgical Corporation | 2012-06-06 | Special | PDF ↗ |
| K112507 | RESTORIS PARTIAL KNEE APPLICATION (PKA), RIO STANDARD SYSTEM | Mako Surgical Corporation | 2012-03-01 | Traditional | PDF ↗ |
| K111811 | BENDINI(TM) SPINAL ROD BENDING SYSTEM | Nuvasive, Inc. | 2011-12-05 | Traditional | PDF ↗ |
| K111843 | ACUFEX DIRECTOR APPLICATION ANATOMIC GUIDE SYSTEM | Smith & Nephew Inc., Endoscopy Div. | 2011-11-14 | Traditional | PDF ↗ |
| K110021 | DASH HIP | Brainlab AG | 2011-10-18 | Traditional | PDF ↗ |
| K111443 | X12 STERILE REFLECTIVE MARKER SPHERE | Pinsco Inc. Dba B & L Engineering | 2011-09-29 | Traditional | PDF ↗ |
| K110204 | BRAINLAB TRAUMA | Brainlab AG | 2011-08-05 | Traditional | PDF ↗ |
| K102251 | DASH KNEE | Brainlab AG | 2011-05-17 | Special | PDF ↗ |
| K110240 | SMITH & NEPHEW, INC. SURESHOT DISTAL TARGETING SYSTEM V2.1 | Smith & Nephew, Inc. | 2011-04-14 | Special | PDF ↗ |
| K103829 | KNEEALIGN SYSTEM | Orthalign, Inc. | 2011-04-04 | Traditional | PDF ↗ |
| K102990 | BRAINLAB KNEE | Brainlab AG | 2011-04-04 | Special | PDF ↗ |
| K110054 | NAVITRACK SYSTEM - OS KNEE UNIVERSAL, CAS SAME INCISION TIBIA REFERENCE | Zimmer Cas | 2011-03-24 | Special | PDF ↗ |
| K103400 | FLUOROMAP SOFTWARE, 9 FLUORODISC (BELT), 12 FLUORO DISC (BELT), CLOSE TUBE CLIP | Stryker Corporation | 2011-03-07 | Traditional | PDF ↗ |
| K102967 | SMITH & NEPHEW, INC. SURESHOT DISTAL TARGETING SYSTEM V2.0.2 | Smith & Newphew, Inc. | 2010-11-04 | Special | PDF ↗ |
| K100742 | EXACTECH GPS | Blue Ortho | 2010-10-21 | Traditional | PDF ↗ |
| K093206 | ORTHOMAP 3D 1.1 MODULE | Stryker Corp. | 2010-08-04 | Traditional | PDF ↗ |
| K093118 | BRAINLAB KNEE ARTHROSCOPY | Brainlab AG | 2010-06-11 | Traditional | PDF ↗ |
| K100599 | CAS FIXATION PIN 3.2 DIA X 180 MM STR, CAS FIXATON PIN 3.2 DIA X 80 MM STR, CAS FIXATON PIN 3.2 DIA X 150 MM | Orthosoft, Inc. | 2010-04-05 | Traditional | PDF ↗ |
| K093998 | KNEEALIGN SYSTEM WITH REFERENCE SENSOR | Orthalign, Inc. | 2010-03-22 | Special | PDF ↗ |
| K093425 | MAKO SURGICAL CORP ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM-THA | Mako Surgical Corp. | 2010-02-24 | Traditional | PDF ↗ |
| K100107 | SMITH & NEPHEW SURESHOT DISTAL TARGETING SYSTEM V2.0 | Smith & Nephew, Inc. | 2010-02-23 | Special | PDF ↗ |
| K090953 | TOTAL KNEE SURGETICS NAVIGATION SYSTEM WITH IBLOCK | Praxim Medivision, SA | 2010-01-21 | Special | PDF ↗ |
| K091998 | ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM-HIP | Mako Surgical Corp. | 2009-09-28 | Traditional | PDF ↗ |
| K091411 | KNEEALIGN SYSTEM | Orthalign, Inc. | 2009-09-25 | Traditional | PDF ↗ |
| K092497 | SMITH & NEPHEW PIGALILEO SCREW TARGETING SYSTEM, VERSION 1.1 | Smith & Nephew, Inc. | 2009-09-11 | Special | PDF ↗ |
| K090375 | ORTHOPILOT NEXT GENERATION-UKA SOFTWARE, MODEL FS210 | Aesculap Implant System, Inc. | 2009-06-23 | Traditional | PDF ↗ |
| K083644 | MAKO SURGICAL TACTILE GUIDANCE SYSTEM-HIP | Mako Surgical Corp. | 2009-06-19 | Traditional | PDF ↗ |
| K090420 | SMITH & NEPHEW PIGALILEO SCREW TARGETING SYSTEM V 1.0 | Smith & Nephew, Inc. | 2009-05-27 | Abbreviated | PDF ↗ |
| K083483 | BRAINLAB HIP UNLIMITED, CI HIP UNLIMITED | Brainlab AG | 2009-04-08 | Traditional | PDF ↗ |
| K083310 | SPINE & TRAUMA ICT | Brainlab AG | 2009-04-01 | Special | PDF ↗ |
| K090313 | PIGALILEO TKR BASE V2.3 AND CAS V4.1 | Smith & Nephew, Inc. | 2009-03-11 | Special | PDF ↗ |
| K083009 | ORTHO-MAP-ONCOLOGY NAVIGATION SOFTWARE, MODELS 6005-650-000, 6005-651-000 | Stryker Leibinger GmbH & Co KG | 2009-02-19 | Traditional | PDF ↗ |
| K083872 | IMNS MEDACTA NAVIGATION SYSTEM | Medacta International S.A. | 2009-01-15 | Traditional | PDF ↗ |
Product code OLO · Class II · Neurology. Data: openFDA.