Identity
- Trade Name
- HammerTech FDA UDI
- Generic Name
- Screw-extraction orthopaedic reamer, single-use FDA UDI
- Device Name
- HT PEEK Removal Tool FDA UDI
- Model / Reference
- CD-HT-1000 FDA UDI
- Description
- HT PEEK Removal Tool FDA UDI
Identifiers
- Catalog Number
- CD-HT-1000 FDA UDI
- Primary DI / UDI-DI
- 00819034027248 FDA UDI
- 510(k) Number
- K182684 FDA UDI
- FDA Product Code
- HWC FDA UDI
- GMDN Term
- Screw-extraction orthopaedic reamer, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Screw-extraction orthopaedic reamer, single-use
HammerTech by Fusion Orthopedics, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Screw-extraction orthopaedic reamer, single-use.
- OPERACE — PB SWISS TOOLS AG · Class I
- 2.7mm Broken Screw Removal System — WISHBONE MEDICAL INC. · Class I
- OPERACE — PB SWISS TOOLS AG · Class I
- PediNail Intramedullary Platform — ORTHOPEDIATRICS CORP. · Class I
- OPERACE — PB SWISS TOOLS AG · Class I
- OPERACE — PB SWISS TOOLS AG · Class I
- OPERACE — PB SWISS TOOLS AG · Class I
- PediNail Intramedullary Platform — ORTHOPEDIATRICS CORP. · Class I
Cleared under the same submission
K182684 also covers:
- Hammer Tech — FUSION ORTHOPEDICS, LLC
- 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
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
- Fusion Orthopedics, Llc
Sources (1)
- FDA UDI 6ae53eb9-d38f-4def-b77f-cefd81f30f22 35 fields · synced Jun 1, 2026