Identity
- Trade Name
- Orthex FDA UDI
- Generic Name
- Orthopaedic intraoperative positioning pin, single-use FDA UDI
- Device Name
- Pear Wire, Sharp Bayonet, 300mm x 1.5mm FDA UDI
- Model / Reference
- K300-15BNP FDA UDI
- Description
- Pear Wire, Sharp Bayonet, 300mm x 1.5mm FDA UDI
Identifiers
- Catalog Number
- K300-15BNP FDA UDI
- Primary DI / UDI-DI
- 00841132179253 FDA UDI
- FDA Product Code
- KTT FDA UDI
- GMDN Term
- Orthopaedic intraoperative positioning pin, single-use 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
No
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Unsafe FDA UDI
Category: Orthopaedic intraoperative positioning pin, single-use
Orthex by Orthopediatrics Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K151881 also covers:
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- Orthex — ORTHOPEDIATRICS CORP.
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- Orthex External Fixation System — ORTHOPEDIATRICS CORP.
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K243798 also covers:
- Orthex — ORTHOPEDIATRICS CORP.
- Orthex — ORTHOPEDIATRICS CORP.
- Orthex — ORTHOPEDIATRICS CORP.
- Orthex — ORTHOPEDIATRICS CORP.
- Orthex — ORTHOPEDIATRICS CORP.
- Orthex — ORTHOPEDIATRICS CORP.
- Orthex — ORTHOPEDIATRICS CORP.
- Orthex — ORTHOPEDIATRICS CORP.
- Orthex External Fixation System — ORTHOPEDIATRICS CORP.
- Orthex External Fixation System — ORTHOPEDIATRICS CORP.
- Orthex External Fixation System — ORTHOPEDIATRICS CORP.
- Orthex External Fixation System — ORTHOPEDIATRICS CORP.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Orthopediatrics Corp.
Sources (1)
- FDA UDI 308ff161-b019-4cbc-bc7c-c6910506cb3b 36 fields · synced Jun 8, 2026