Aesculap Hydrolift VBR System
FDA 510(k) K083186 · Aesculap Implant System, Inc.
510(k) numberK083186
Submission
- Device name
- Aesculap Hydrolift VBR System
- Applicant
- Aesculap Implant System, Inc.
Center Valley, PA, US - Received
- October 29, 2008
- Decision date
- March 4, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MQP – Spinal Vertebral Body Replacement Device
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3060
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code MQP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261810 | Vertiwedge® Intraosseous SystemMQP · Special | Foundation Surgical Group | 07/31/2026SE |
| K261031 | Poseidon STMQP · Traditional | Signus Medinzintechnik GmbH | 07/10/2026SE |
| K253158 | VyBrate VBR SystemMQP · Traditional | Vy Spine, LLC | 01/07/2026SE |
| K241468 | Vertiwedge® Intraosseous SystemMQP · Traditional | Foundation Surgical Group, Inc. | 11/07/2024SE |
| K232790 | KONG®-TL VBR System and KONG® C VBR SystemMQP · Traditional | Icotec AG | 04/04/2024SE |
| K233359 | DOMINION Expandable Corpectomy SystemMQP · Traditional | Astura Medical | 03/08/2024SE |
| K231134 | VerteLoc Spinal SystemMQP · Traditional | Signature Orthopaedics Pty, Ltd. | 02/13/2024SE |
| K232173 | Ascend VBR System, Ascend NanoTec VBR SystemMQP · Traditional | Alphatec Spine, Inc. | 10/06/2023SE |
| K211892 | ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages)MQP · Traditional | Arftx Medical, LLC | 10/06/2022SE |
| K202637 | F3D Corpectomy SystemMQP · Traditional | Corelink, LLC | 12/23/2020SE |
More from Corelink, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K142707 | AIS Odontoid Fracture Fixation SystemHWC · Traditional | 12/19/2014SE |
| K142150 | Ais Modulift VBR SystemMQP · Traditional | 10/29/2014SE |
| K133802 | Ais Modulift VBR SystemMQP · Traditional | 04/17/2014SE |
| K122783 | Plasmafit Acetabular Cup and Vitelene InsertOQG · Traditional | 10/30/2013SE |
| K130887 | S4C Navigation InstrumentsOLO · Traditional | 08/13/2013SE |
| K123909 | Aesculap Cespace XPODP · Traditional | 04/15/2013SE |
| K130291 | S4 Spinal SystemNKB · Traditional | 04/11/2013SE |
| K122985 | Columbus Revision Knee SystemJWH · Special | 10/26/2012SE |
| K112551 | S4 Spinal SystemNKB · Special | 11/21/2011SE |
| K101281 | Vega Knee SystemJWH · Traditional | 07/30/2010SE |
Questions and answers
When was Aesculap Hydrolift VBR System cleared by the FDA?
Aesculap Hydrolift VBR System (K083186) received a 510(k) decision of Substantially Equivalent on March 4, 2010, 491 days after the submission was received.
What is the product code of K083186?
The FDA product code is MQP – Spinal Vertebral Body Replacement Device, a Class II (moderate risk) device regulated under 21 CFR 888.3060.