Company ยท US
Aesculap Implant System, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2007 to 2014. Name variants (Inc, Corp, punctuation) are merged.
18510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 3 |
| MQP | Spinal Vertebral Body Replacement Device | 3 |
| NKB | Thoracolumbosacral Pedicle Screw System | 3 |
| OLO | Orthopedic Stereotaxic Instrument | 2 |
| HAW | Neurological Stereotaxic Instrument | 1 |
| HWC | Screw, Fixation, Bone | 1 |
| MAI | Fastener, Fixation, Biodegradable, Soft Tissue | 1 |
| MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | 1 |
| NQW | Orthosis, Spine, Plate, Laminoplasty, Metal | 1 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 1 |
| OQG | Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 19, 2014 | K142707 | AIS Odontoid Fracture Fixation System Aesculap Implant System, Inc. | HWC |
| Oct 29, 2014 | K142150 | AIS MODULIFT VBR SYSTEM Aesculap Implant System, Inc. | MQP |
| Apr 17, 2014 | K133802 | AIS MODULIFT VBR SYSTEM Aesculap Implant System, Inc. | MQP |
| Oct 30, 2013 | K122783 | PLASMAFIT ACETABULAR CUP AND VITELENE INSERT Aesculap Implant System, Inc. | OQG |
| Aug 13, 2013 | K130887 | S4C NAVIGATION INSTRUMENTS Aesculap Implant System, Inc. | OLO |
| Apr 15, 2013 | K123909 | AESCULAP CESPACE XP Aesculap Implant System, Inc. | ODP |
| Apr 11, 2013 | K130291 | S4 SPINAL SYSTEM Aesculap Implant System, Inc. | NKB |
| Oct 26, 2012 | K122985 | COLUMBUS REVISION KNEE SYSTEM Aesculap Implant System, Inc. | JWH |
| Nov 21, 2011 | K112551 | S4 SPINAL SYSTEM Aesculap Implant System, Inc. | NKB |
| Jul 30, 2010 | K101281 | VEGA KNEE SYSTEM Aesculap Implant System, Inc. | JWH |
| Jul 23, 2010 | K100147 | S4 CERVICAL OCCIPITAL PLATE SPINAL SYSTEM Aesculap Implant System, Inc. | NKB |
| Mar 4, 2010 | K083186 | AESCULAP HYDROLIFT VBR SYSTEM Aesculap Implant System, Inc. | MQP |
| Jun 23, 2009 | K090375 | ORTHOPILOT NEXT GENERATION-UKA SOFTWARE, MODEL FS210 Aesculap Implant System, Inc. | OLO |
| Jun 4, 2009 | K083772 | COLUMBUS REVISION KNEE SYSTEM Aesculap Implant System, Inc. | JWH |
| May 12, 2009 | K090354 | LAMINOPLASTY PLATING SYSTEM Aesculap Implant System, Inc. | NQW |
| May 23, 2008 | K080547 | ORTHOPILOT NEXT GENERATION, MODEL FS101-FS106 Aesculap Implant System, Inc. | HAW |
| May 9, 2008 | K080584 | METHA SHORT STEM HIP SYSTEM Aesculap Implant System, Inc. | MEH |
| Apr 30, 2007 | K070178 | AESCULAP RESORBABLE PIN, MODEL FR735 Aesculap Implant System, Inc. | MAI |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||