510(k) clearance
S.I.N. Instruments Kits
- 510(k) number
- K262084
- Applicant
- S.I.N. Implant System Ltda
- Decision date
- Oct 22, 2026
- Date received
- Jun 22, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- KCT
- Device type
- Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
- Device class
- Class II
- Regulation
- 21 CFR 880.6850
- Advisory committee
- General Hospital
- Statement or summary
- Summary
- Third party
- N
- Location
- São Paulo, BR