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DRACO Locking Bone Screws - DRACO Compression Screws
FDA 510(k)Class II (US FDA 510(k))
510(k) K163486
Identifiers
- 510(k) Number
- K163486 FDA 510(k)
- FDA Product Code
- KTT FDA 510(k)
- Models / Variants
- DRACO Locking Bone Screws FDA 510(k)DRACO Compression Screws FDA 510(k)DRACO MetaFuse L Plates FDA 510(k)DRACO MetaFuse BLP Plates FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3030 FDA 510(k)
- Regulation Number
- 888.3030 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
DRACO Locking Bone Screws - DRACO Compression Screws by Hnm Total Recon Llc — Class II — FDA_510K — listed in FDA 510(k) — 5 models
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 | K163486 | Class II | Active |
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Manufacturer
- Manufacturer
- Hnm Total Recon Llc
- FDA Applicant
- Hnm Total Recon, LLC
Sources (1)
- FDA 510(k) K163486 24 fields · synced Jun 18, 2026