Identity
- Trade Name
- Hammer Tech FDA UDI
- Generic Name
- Instrument tray, reusable FDA UDI
- Device Name
- TI Tray FDA UDI
- Model / Reference
- TN-TR-0007 FDA UDI
- Description
- TI Tray FDA UDI
Identifiers
- Catalog Number
- TN-TR-0007 FDA UDI
- Primary DI / UDI-DI
- 00852164007353 FDA UDI
- 510(k) Number
- K182684 FDA UDI
- FDA Product Code
- HJO FDA UDI
- GMDN Term
- Instrument tray, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 886.1850 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Instrument tray, reusable
Hammer Tech by Fusion Orthopedics, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Instrument tray, reusable.
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- Instrument Case — Katena Products, Inc. · Class I
- Hu-Friedy — Hu-Friedy Manufacturing Co., LLC · Class I
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- SHEFFIELD RING FIXATOR — Orthofix, Inc. · Class II
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Cleared under the same submission
K182684 also covers:
- Hammer Tech — FUSION ORTHOPEDICS, LLC
- HammerTech — FUSION ORTHOPEDICS, LLC
- HammerTech — FUSION ORTHOPEDICS, LLC
- HammerTech — FUSION ORTHOPEDICS, LLC
- HammerTech — FUSION ORTHOPEDICS, LLC
- HammerTech — FUSION ORTHOPEDICS, LLC
- HammerTech — FUSION ORTHOPEDICS, LLC
- HammerTech — FUSION ORTHOPEDICS, LLC
- HammerTech — FUSION ORTHOPEDICS, LLC
- HammerTech — FUSION ORTHOPEDICS, LLC
- HammerTech — FUSION ORTHOPEDICS, LLC
- HammerTech — FUSION ORTHOPEDICS, LLC
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
- Fusion Orthopedics, Llc
Sources (1)
- FDA UDI c35bf891-b222-41d5-b876-690aaedca1e3 35 fields · synced May 30, 2026