Identity
- Trade Name
- Dynamic Device FDA UDI
- Generic Name
- Orthopaedic fixation plate tensioner FDA UDI
- Device Name
- Dynamic Device FDA UDI
- Model / Reference
- DD00 FDA UDI
- Description
- Dynamic Device FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810054091097 FDA UDI
- 510(k) Number
- K191118 FDA UDI
- FDA Product Code
- HRS FDA UDIHWC FDA UDI
- GMDN Term
- Orthopaedic fixation plate tensioner FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3030 FDA UDI888.3040 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 fixation plate tensioner
Dynamic Device by Avanti Orthopaedics Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic fixation plate tensioner.
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- TENSIONER HEAD, CANNULATED — Biomet Orthopedics, Inc. · Class I
- LARGE FRAG TENSIONER — Biomet Orthopedics, Inc. · Class I
- Apelo® / Apelo® MIS — ATLAS SPINE INC. · Class I
- Made-To-Order — TORNIER, INC. · Class I
- Aequalis Resurfacing Head — TORNIER, INC. · Class I
Cleared under the same submission
K191118 also covers:
- Aiming Guide, 2.0mm — AVANTI ORTHOPAEDICS LLC
- Assembled Screw Driver, 1.7mm — AVANTI ORTHOPAEDICS LLC
- Avanti Cannulated Countersink, 2.7mm — AVANTI ORTHOPAEDICS LLC
- Cannulated Screw, 2.7mm x 14mm Long — AVANTI ORTHOPAEDICS LLC
- Cannulated Screw, 2.7mm x 18mm Long — AVANTI ORTHOPAEDICS LLC
- Cannulated Screw, 2.7mm x 20mm Long — AVANTI ORTHOPAEDICS LLC
- Cannulated Screw, 2.7mm x 22mm Long — AVANTI ORTHOPAEDICS LLC
- Cannulated Screw, 2.7mm x 26mm Long — AVANTI ORTHOPAEDICS LLC
- Cannulated Screw, 2.7mm x 28mm Long — AVANTI ORTHOPAEDICS LLC
- Cannulated Screw, 2.7mm x 32mm Long — AVANTI ORTHOPAEDICS LLC
- Cannulated Screw, 2.7mm x 34mm Long — AVANTI ORTHOPAEDICS LLC
- Cannulated Screw, 2.7mm x 36mm Long — AVANTI ORTHOPAEDICS 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
- Avanti Orthopaedics Llc
Sources (1)
- FDA UDI d8cc034f-3484-43d2-a4a9-e7e25e3c84c1 35 fields · synced May 30, 2026