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Remplir (ON-152, 15 x 20 mm) +3 more models
FDA 510(k)Class II (US FDA 510(k))
510(k) K243889
Identifiers
- 510(k) Number
- K243889 FDA 510(k)
- FDA Product Code
- JXI FDA 510(k)
- Models / Variants
- Remplir (ON-152, 15 x 20 mm) FDA 510(k)Remplir (ON-203, 20 x 30 mm) FDA 510(k)Remplir (ON-304, 30 x 40 mm) FDA 510(k)Remplir (ON-405, 40 x 50 mm) FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.5275 FDA 510(k)
- Regulation Number
- 882.5275 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Remplir (ON-152, 15 x 20 mm) +3 more models by Orthocell Ltd — Class II — FDA_510K — listed in FDA 510(k) — 4 models — regulatory data on deviCERTS
Manufacturer's product page: Remplir
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K243889 | Class II | Active |
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Manufacturer
- Manufacturer
- Orthocell Ltd
- FDA Applicant
- Orthocell, Ltd.
Sources (1)
- FDA 510(k) K243889 24 fields · synced Jun 18, 2026