Identity
- Trade Name
- UNIVERSAL HUMERAL FLUSH IMPING FDA UDI
- Generic Name
- Bone nail end-cap FDA UDI
- Model / Reference
- 1817-01-001 FDA UDI
Identifiers
- Catalog Number
- 181701001 FDA UDI
- Primary DI / UDI-DI
- 00887868021565 FDA UDI
- FDA Product Code
- HSB FDA UDI
- GMDN Term
- Bone nail end-cap FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3020 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Bone nail end-cap
Universal Humeral Flush Imping by Biomet Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bone nail end-cap.
- Phantom® Fibula Nail System — Paragon 28 · Class II
- Micro Screws (INOX) — devemed GmbH · Class IIb
- AJAX Nail — Auxein Medical Private Limited · Class II
- PNP Femur — ORTHOPEDIATRICS CORP. · Class II
- PNP Femur — ORTHOPEDIATRICS CORP. · Class II
- EXPert Nail — Synthes · Class II
- EXPert Nail — Synthes · Class II
- Micro Screws (INOX) — devemed GmbH · Class IIb
Cleared under the same submission
K033329 also covers:
- UNIVERSAL HUMERAL — Biomet Orthopedics, Inc.
- UNIVERSAL HUMERAL ADD 5MM IMPING 1ST — Biomet Orthopedics, Inc.
- UNIVERSAL HUMERAL ADD 5MM IMPING 2ND — Biomet Orthopedics, Inc.
- UNIVERSAL HUMERAL FLUSH IMPING 2ND SCREW — Biomet Orthopedics, Inc.
- Universal Humeral Flush End Cap — Biomet Orthopedics, Inc.
- Universal Humeral Flush End Cap — Biomet Orthopedics, Inc.
- Universal Humeral Flush End Cap — Biomet Orthopedics, Inc.
- Universal Humeral Flush End Cap — Biomet Orthopedics, Inc.
- Universal Humeral Flush End Cap — Biomet Orthopedics, Inc.
- VERSANAIL®UNIVERSAL HUMERAL NAIL — Biomet Orthopedics, Inc.
- VERSANAIL®UNIVERSAL HUMERAL NAIL — Biomet Orthopedics, Inc.
- VERSANAIL®UNIVERSAL HUMERAL NAIL — Biomet Orthopedics, Inc.
K033878 also covers:
- IM NAIL PLATFORM — Biomet Orthopedics, Inc.
- IM NAIL PLATFORM — Biomet Orthopedics, Inc.
- IM NAIL PLATFORM — Biomet Orthopedics, Inc.
- IM NAIL PLATFORM — Biomet Orthopedics, Inc.
- IM NAIL PLATFORM — Biomet Orthopedics, Inc.
- IM NAIL PLATFORM — Biomet Orthopedics, Inc.
- IM NAIL PLATFORM — Biomet Orthopedics, Inc.
- IM NAIL PLATFORM — Biomet Orthopedics, Inc.
- IM NAIL PLATFORM — Biomet Orthopedics, Inc.
- IM NAIL PLATFORM — Biomet Orthopedics, Inc.
- IM NAIL PLATFORM — Biomet Orthopedics, Inc.
- IM NAIL PLATFORM — Biomet Orthopedics, 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Biomet Orthopedics, Inc.
Sources (1)
- FDA UDI 6e6b3975-46ab-41fa-900d-b8c6df580077 35 fields · synced May 30, 2026