Identity
- Trade Name
- 3P Hip System FDA UDI
- Generic Name
- Implantable orthopaedic/craniofacial device connection screw FDA UDI
- Device Name
- Adolescent Connector Bolt, Cannulated FDA UDI
- Model / Reference
- 00-3000-3000 FDA UDI
- Description
- Adolescent Connector Bolt, Cannulated FDA UDI
Identifiers
- Catalog Number
- 00-3000-3000 FDA UDI
- Primary DI / UDI-DI
- 00840194472661 FDA UDI
- 510(k) Number
- K243963 FDA UDI
- FDA Product Code
- JDO FDA UDI
- GMDN Term
- Implantable orthopaedic/craniofacial device connection screw 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
Yes
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 Conditional FDA UDI
Category: Implantable orthopaedic/craniofacial device connection screw
3P Hip System by Orthopediatrics Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Implantable orthopaedic/craniofacial device connection screw.
- PolyLock — FUSION ORTHOPEDICS, LLC · Class II
- IMPlate — SKELETAL DYNAMICS L.L.C. · Class II
- HammerTech — FUSION ORTHOPEDICS, LLC · Class II
- PolyLock — FUSION ORTHOPEDICS, LLC · Class II
- SkyOPS — SKY SURGICAL · Class II
- LINK Endo-Model EVO Knee System — WALDEMAR LINK GmbH & Co. KG · Class II
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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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Orthopediatrics Corp.
Sources (1)
- FDA UDI 7d6da761-d18b-4976-a9b0-7a5fc5aaa4e2 36 fields · synced May 30, 2026