Pegasus-X Expandable PLIF System
FDA 510(k) K221687 · GS Medical Co., Ltd.
510(k) numberK221687
Submission
- Device name
- Pegasus-X Expandable PLIF System
- Applicant
- GS Medical Co., Ltd.
Cheongju-Si, KR - Received
- June 10, 2022
- Decision date
- July 27, 2022
- 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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Questions and answers
When was Pegasus-X Expandable PLIF System cleared by the FDA?
Pegasus-X Expandable PLIF System (K221687) received a 510(k) decision of Substantially Equivalent on July 27, 2022, 47 days after the submission was received.
What is the product code of K221687?
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.