Identity
- Trade Name
- LSP Titanium Humeral Plate FDA UDI
- Generic Name
- Orthopaedic bone wire FDA UDI
- Device Name
- K-WIRES (D. 2MM) L. 200MM (PACK OF 4) STERILE FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- K-WIRES (D. 2MM) L. 200MM (PACK OF 4) STERILE FDA UDI
Identifiers
- Catalog Number
- 99-TP1111 FDA UDI
- Primary DI / UDI-DI
- 18054242510505 FDA UDI
- 510(k) Number
- K062920 FDA UDI
- FDA Product Code
- KTW FDA UDI
- GMDN Term
- Orthopaedic bone wire FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3030 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Length — 200 Millimeter FDA UDIOuter Diameter — 2 Millimeter FDA UDI
Category: Orthopaedic bone wire
LSP Titanium Humeral Plate by Orthofix, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic bone wire.
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- SMOOTH K-WIRE, DOUBLE END TROCAR POINT — Biomet Orthopedics, Inc. · Class II
- mahe medical GmbH — mahe medical gmbh · Class II
- OIC Variable Angle Small Fragment Locking Plate System — ORTHOPAEDIC IMPLANT COMPANY, THE · Class II
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Cleared under the same submission
K062920 also covers:
- CONTOURS PROXIMAL HUMERAL PLATE (PHP) & LSP TITANIUM HUMERAL PLATE — Orthofix, Inc.
- CONTOURS PROXIMAL HUMERAL PLATE (PHP) & LSP TITANIUM HUMERAL PLATE — Orthofix, Inc.
- CONTOURS PROXIMAL HUMERAL PLATE (PHP) & LSP TITANIUM HUMERAL PLATE — Orthofix, Inc.
- CONTOURS PROXIMAL HUMERAL PLATE (PHP) & LSP TITANIUM HUMERAL PLATE — Orthofix, Inc.
- CONTOURS PROXIMAL HUMERAL PLATE (PHP) & LSP TITANIUM HUMERAL PLATE — Orthofix, Inc.
- Contours Proximal Humeral Plate (Php) & Lsp Titanium Humeral Plate — Orthofix, Inc.
- Contours Proximal Humeral Plate (Php) & Lsp Titanium Humeral Plate — Orthofix, Inc.
- Contours Proximal Humeral Plate (Php) & Lsp Titanium Humeral Plate — Orthofix, Inc.
- Contours Proximal Humeral Plate (Php) & Lsp Titanium Humeral Plate — Orthofix, Inc.
- Contours Proximal Humeral Plate (Php) & Lsp Titanium Humeral Plate — Orthofix, Inc.
- Contours Proximal Humeral Plate (Php) & Lsp Titanium Humeral Plate — Orthofix, Inc.
- Contours Proximal Humeral Plate (Php) & Lsp Titanium Humeral Plate — Orthofix, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Orthofix, Inc.
Sources (1)
- FDA UDI 658c4d15-28cf-42b9-a651-a4d8f48c506e 37 fields · synced Jun 1, 2026