Identity
- Trade Name
- NovoHip Total Hip System FDA UDI
- Generic Name
- Instrument tray, reusable FDA UDI
- Device Name
- Femoral Prep Upper Tray - Short Rasp FDA UDI
- Model / Reference
- 1713-154-201 FDA UDI
- Description
- Femoral Prep Upper Tray - Short Rasp FDA UDI
Identifiers
- Catalog Number
- 1713-154-201 FDA UDI
- Primary DI / UDI-DI
- 00811382038945 FDA UDI
- 510(k) Number
- K140701 FDA UDI
- FDA Product Code
- OQG FDA UDILPH FDA UDILZO FDA UDILXH FDA UDI
- GMDN Term
- Instrument tray, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3358 FDA UDI888.3353 FDA UDI888.4540 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: Instrument tray, reusable
NovoHip Total Hip System by Novosource, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K140701 also covers:
- NovoHip Total Hip System — Novosource, Inc.
- NovoHip Total Hip System — Novosource, Inc.
- NovoHip Total Hip System — Novosource, Inc.
- NovoHip Total Hip System — Novosource, Inc.
- NovoHip Total Hip System — Novosource, Inc.
- NovoHip Total Hip System — Novosource, Inc.
- NovoHip Total Hip System — Novosource, Inc.
- NovoHip Total Hip System — Novosource, Inc.
- NovoHip Total Hip System — Novosource, Inc.
- NovoHip Total Hip System — Novosource, Inc.
- NovoHip Total Hip System — Novosource, Inc.
- NovoHip Total Hip System — Novosource, 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
- Novosource, Inc.
Sources (1)
- FDA UDI 277961df-54c0-477a-8a7f-0c0bd063f543 36 fields · synced May 31, 2026