Remplir (4 models)— 510(k) K243889
Substantially EquivalentOrthocell, Ltd.
FDA 510(k) clearance K243889 for Remplir (4 models), Substantially Equivalent on 2025-04-02. Applicant: Orthocell, Ltd.. Device class: 2.
Clearance details
- Device name as filed
- Remplir (ON-152, 15 x 20 mm); Remplir (ON-203, 20 x 30 mm); Remplir (ON-304, 30 x 40 mm); Remplir (ON-405, 40 x 50 mm)
- Applicant
- Orthocell, Ltd.
- Product code
- Code JXI
- Device class
- Class 2
- Regulation
- 21 CFR 882.5275
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Murdoch, AU
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