Halis Lumbar Cage System, Lydia Anterior Lumbar Fusion System, Dica Direction Changeable Lumbar Cage System, KEYSTONE Cage System
FDA 510(k) K230872 · Shanghai Sanyou Medical Co, Ltd.
510(k) numberK230872
Submission
- Device name
- Halis Lumbar Cage System, Lydia Anterior Lumbar Fusion System, Dica Direction Changeable Lumbar Cage System, KEYSTONE Cage System
- Applicant
- Shanghai Sanyou Medical Co, Ltd.
Jiading District, CN - Received
- March 30, 2023
- Decision date
- December 12, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MAX – Intervertebral Fusion Device With Bone Graft, Lumbar
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3080
- Specialty
- Orthopedic
- Implant
- Yes
Intended to stabilize spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.
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More from Life Spine, Inc.
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|---|---|---|
| K230961 | Zeus Spinal SystemNKB · Special | 10/10/2023SE |
| K231931 | Adena-Zina Spinal SystemNKB · Special | 07/28/2023SE |
| K211689 | KEYSTONE PEEK Cage SystemMAX · Traditional | 09/21/2021SE |
| K212066 | Adena-Zina SystemNKB · Traditional | 08/16/2021SE |
| K163366 | Shanghai Sanyou CARMEN Cervical Fusion SystemKWQ · Traditional | 10/05/2017SE |
| K163422 | Shanghai Sanyou PEEK Cage SystemODP · Traditional | 09/18/2017SE |
| K152781 | Adena-Zina SystemNKB · Traditional | 02/12/2016SE |
| K131512 | Katia SystemKWQ · Traditional | 08/07/2013SE |
Questions and answers
When was Halis Lumbar Cage System, Lydia Anterior Lumbar Fusion System, Dica Direction Changeable Lumbar Cage System, KEYSTONE Cage System cleared by the FDA?
Halis Lumbar Cage System, Lydia Anterior Lumbar Fusion System, Dica Direction Changeable Lumbar Cage System, KEYSTONE Cage System (K230872) received a 510(k) decision of Substantially Equivalent on December 12, 2023, 257 days after the submission was received.
What is the product code of K230872?
The FDA product code is MAX – Intervertebral Fusion Device With Bone Graft, Lumbar, a Class II (moderate risk) device regulated under 21 CFR 888.3080.