Identity
- Trade Name
- DINAMIC T HUMERUS FDA UDI
- Generic Name
- Orthopaedic bone-fragment manipulator, reusable FDA UDI
- Model / Reference
- Fracture alignment and guide wire exchange tool FDA UDI
Identifiers
- Catalog Number
- DT070015 FDA UDI
- Primary DI / UDI-DI
- 08032909629749 FDA UDI
- 510(k) Number
- K113387 FDA UDI
- FDA Product Code
- HSB FDA UDI
- GMDN Term
- Orthopaedic bone-fragment manipulator, reusable 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
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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Orthopaedic bone-fragment manipulator, reusable
Dinamic T Humerus by Citieffe — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic bone-fragment manipulator, reusable.
- Surgical Direct — SURGICAL DIRECT, INC. · Class I
- Medium Reduction Forceps — BIOPRO, INC. · Class I
- MSI Precision Specialty Instruments — Med Saver, Inc. · Class I
- Surgical Direct — SURGICAL DIRECT, INC. · Class I
- Surgical Direct — SURGICAL DIRECT, INC. · Class I
- Surgical Direct — SURGICAL DIRECT, INC. · Class I
- Surgical Direct — SURGICAL DIRECT, INC. · Class I
- Surgical Direct — SURGICAL DIRECT, INC. · Class I
Cleared under the same submission
K113387 also covers:
- DINAMIC T HUMERUS — Citieffe
- DINAMIC T HUMERUS — Citieffe
- DINAMIC T HUMERUS — Citieffe
- DINAMIC T HUMERUS — Citieffe
- DINAMIC T HUMERUS — Citieffe
- DINAMIC T HUMERUS — Citieffe
- DINAMIC T HUMERUS — Citieffe
- DINAMIC T HUMERUS — Citieffe
- DINAMIC T HUMERUS — Citieffe
- DINAMIC T HUMERUS — Citieffe
- DINAMIC T HUMERUS — Citieffe
- DINAMIC T HUMERUS — Citieffe
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
- Citieffe
Sources (1)
- FDA UDI fd5374fb-d5f6-4e75-834d-33ef64680b7e 36 fields · synced May 30, 2026