Addplus
FDA 510(k) K090841 · Ulrich GmbH & Co. KG
510(k) numberK090841
Submission
- Device name
- Addplus
- Applicant
- Ulrich GmbH & Co. KG
St. Louis, MO, US - Received
- March 27, 2009
- Decision date
- October 5, 2009
- 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 |
|---|---|---|
| K252281 | ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT…IZQ · Traditional | 11/18/2025SE |
| K251295 | ulrichINJECT CT Motion (XD 8000)IZQ · Traditional | 11/07/2025SE |
| K241850 | ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT…IZQ · Traditional | 08/26/2024SE |
| K233737 | ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT…IZQ · Traditional | 04/19/2024SE |
| K210541 | ulrichINJECT CT motionIZQ · Traditional | 08/06/2021SE |
| K202227 | Artus cervical plate systemKWQ · Traditional | 09/14/2020SE |
| K192872 | ulrichINJECT CT MotionIZQ · Traditional | 07/02/2020SE |
| K192117 | Small VBRMQP · Traditional | 11/01/2019SE |
| K171392 | ulrichINJECT CT motionIZQ · Traditional | 11/09/2017SE |
| K161032 | neon3 universal OCT spinal stabilizationNKG · Traditional | 12/22/2016SE |
Questions and answers
When was Addplus cleared by the FDA?
Addplus (K090841) received a 510(k) decision of Substantially Equivalent on October 5, 2009, 192 days after the submission was received.
What is the product code of K090841?
The FDA product code is MQP – Spinal Vertebral Body Replacement Device, a Class II (moderate risk) device regulated under 21 CFR 888.3060.