Zenius Spinal System
by Medyssey Co., Ltd. 2 variants
510(k) K103272
Zenius Spinal System is a Class II device made by Medyssey Co., Ltd., cleared under FDA 510(k) K103272 on 29 Dec 2010, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK103272 | Date29 Dec 2010 | StatusActive |
Official records
- FDA 510(k) database K103272
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- MNI
- FDA applicant
- Medyssey Co, Ltd.
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3070
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
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