Identity
- Trade Name
- Orthex FDA UDI
- Generic Name
- Orthopaedic intraoperative positioning pin, single-use FDA UDI
- Device Name
- Wire, Sharp Bayonet, 200mm x 2.0mm FDA UDI
- Model / Reference
- K200-20BN FDA UDI
- Description
- Wire, Sharp Bayonet, 200mm x 2.0mm FDA UDI
Identifiers
- Catalog Number
- K200-20BN FDA UDI
- Primary DI / UDI-DI
- 00841132179208 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
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:
- Orthex — ORTHOPEDIATRICS CORP.
- Orthex — ORTHOPEDIATRICS CORP.
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- Orthex — ORTHOPEDIATRICS CORP.
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- Orthex External Fixation System — ORTHOPEDIATRICS CORP.
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- Orthex — VILEX IN TENNESSEE, INC.
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 |
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Manufacturer
- Manufacturer
- Orthopediatrics Corp.
Sources (1)
- FDA UDI 05c8ffb8-7b64-40f1-9ece-9390beca3a5b 36 fields · synced Jun 8, 2026