Arthroplane
510(k) K932869
Arthroplane is a Class II device made by Synvasive Technology, Inc., cleared under FDA 510(k) K932869 on 25 Mar 1994, 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 | NumberK932869 | Date25 Mar 1994 | StatusActive |
Official records
- FDA 510(k) database K932869
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- HRX
- Device class
- Class II
- Regulation
- 21 CFR Part 888.1100
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
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