Aesculap Implant System, Inc.
Center Valley, PA, US
Aesculap Implant System, Inc. appears in FDA device records in Center Valley, PA. FDA records list 18 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 18
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 18 510(k) clearances for Aesculap Implant System, Inc. between 2007 and 2014. The busiest year on record is 2013, with 4. The most recent is 2014, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2007 | 1 |
| 2008 | 2 |
| 2009 | 3 |
| 2010 | 3 |
| 2011 | 1 |
| 2012 | 1 |
| 2013 | 4 |
| 2014 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K142707 | AIS Odontoid Fracture Fixation System | HWC | Substantially Equivalent | |
| K142150 | AIS MODULIFT VBR SYSTEM | MQP | Substantially Equivalent | |
| K133802 | AIS MODULIFT VBR SYSTEM | MQP | Substantially Equivalent | |
| K122783 | PLASMAFIT ACETABULAR CUP AND VITELENE INSERT | OQG | Substantially Equivalent | |
| K130887 | S4C NAVIGATION INSTRUMENTS | OLO | Substantially Equivalent | |
| K123909 | AESCULAP CESPACE XP | ODP | Substantially Equivalent | |
| K130291 | S4 SPINAL SYSTEM | NKB | Substantially Equivalent | |
| K122985 | COLUMBUS REVISION KNEE SYSTEM | JWH | Substantially Equivalent | |
| K112551 | S4 SPINAL SYSTEM | NKB | Substantially Equivalent | |
| K101281 | VEGA KNEE SYSTEM | JWH | Substantially Equivalent | |
| K100147 | S4 CERVICAL OCCIPITAL PLATE SPINAL SYSTEM | NKB | Substantially Equivalent | |
| K083186 | AESCULAP HYDROLIFT VBR SYSTEM | MQP | Substantially Equivalent | |
| K090375 | ORTHOPILOT NEXT GENERATION-UKA SOFTWARE, MODEL FS210 | OLO | Substantially Equivalent | |
| K083772 | COLUMBUS REVISION KNEE SYSTEM | JWH | Substantially Equivalent | |
| K090354 | LAMINOPLASTY PLATING SYSTEM | NQW | Substantially Equivalent | |
| K080547 | ORTHOPILOT NEXT GENERATION, MODEL FS101-FS106 | HAW | Substantially Equivalent | |
| K080584 | METHA SHORT STEM HIP SYSTEM | MEH | Substantially Equivalent | |
| K070178 | AESCULAP RESORBABLE PIN, MODEL FR735 | MAI | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- MAIFastener, Fixation, Biodegradable, Soft Tissue
- OQGHip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented
- ODPIntervertebral Fusion Device With Bone Graft, Cervical
- HAWNeurological Stereotaxic Instrument
- OLOOrthopedic Stereotaxic Instrument
- NQWOrthosis, Spine, Plate, Laminoplasty, Metal
- MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
- JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- HWCScrew, Fixation, Bone
- MQPSpinal Vertebral Body Replacement Device
- NKBThoracolumbosacral Pedicle Screw System
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain