Identity
- Trade Name
- 3P Hip System FDA UDI
- Generic Name
- Bone-angle protractor FDA UDI
- Device Name
- 3P Adolescent Beam - Osteotomy Reference FDA UDI
- Model / Reference
- 01-3002-3001 FDA UDI
- Description
- 3P Adolescent Beam - Osteotomy Reference FDA UDI
Identifiers
- Catalog Number
- 01-3002-3001 FDA UDI
- Primary DI / UDI-DI
- 00841132185483 FDA UDI
- 510(k) Number
- K243963 FDA UDI
- FDA Product Code
- HRS FDA UDI
- GMDN Term
- Bone-angle protractor 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
No
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: Bone-angle protractor
3P Hip System by Orthopediatrics Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- 3P Hip System — ORTHOPEDIATRICS CORP. · Class II
- 3P Hip System — ORTHOPEDIATRICS CORP. · Class I
Cleared under the same submission
K243963 also covers:
- 3P Hip System — ORTHOPEDIATRICS CORP.
- 3P Hip System — ORTHOPEDIATRICS CORP.
- 3P Hip System — ORTHOPEDIATRICS CORP.
- 3P Hip System — ORTHOPEDIATRICS CORP.
- 3P Hip System — ORTHOPEDIATRICS CORP.
- 3P Hip System — ORTHOPEDIATRICS CORP.
- 3P Hip System — ORTHOPEDIATRICS CORP.
- 3P Hip System — ORTHOPEDIATRICS CORP.
- 3P Hip System — ORTHOPEDIATRICS CORP.
- 3P Hip System — ORTHOPEDIATRICS CORP.
- 3P Hip System — ORTHOPEDIATRICS CORP.
- 3P Hip 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 08642424-1f2f-4f72-bc57-ce02b8c647c5 36 fields · synced May 30, 2026