FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇷 France
LARS ACJ
K Number: K253115
·
Decision Jun 10, 2026
Classifications
1
FEI Numbers
272
Registration Numbers
272
Same Product Code
92
Applicant Total
1
Review Days
259
Basic Information
- Device Name
- LARS ACJ
- K Number
- K253115
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Movmedix S.A.S.
- Date Received
- September 24, 2025
- Decision Date
- June 10, 2026
- Product Code
- HTN
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HTN | Washer, Bolt Nut | FDA class 2 | Orthopedic |
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