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PERLA® TL System +1 more model
FDA 510(k)Class II (US FDA 510(k))
510(k) K230774
by Spineart
Identifiers
- 510(k) Number
- K230774 FDA 510(k)
- FDA Product Code
- PML FDA 510(k)
- Models / Variants
- PERLA® TL System FDA 510(k)TEKTONA® HV US Bone Cement FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3027 FDA 510(k)
- Regulation Number
- 888.3027 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
PERLA® TL System +1 more model by Spineart — Class II — FDA_510K — listed in FDA 510(k) — 2 models — regulatory data on deviCERTS
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 | K230774 | Class II | Active |
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Manufacturer
- Manufacturer
- Spineart
Sources (1)
- FDA 510(k) K230774 24 fields · synced Jun 18, 2026