Identity
- Trade Name
- Trajectory Wire, DynaFuse FDA UDI
- Generic Name
- Bone access channel kit FDA UDI
- Model / Reference
- 3100-04-0001 FDA UDI
Identifiers
- Primary DI / UDI-DI
- M97031000400010 FDA UDI
- 510(k) Number
- K203595 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Bone access channel kit FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 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
No
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
Moist Heat or Steam Sterilization FDA UDI
Category: Bone access channel kit
Trajectory Wire, DynaFuse by Medshape, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Bone access channel kit.
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- Drill — Shanghai Kinetic Medical Co., Ltd. · Class II
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Cleared under the same submission
K203595 also covers:
- Depth Gauge, 150mm DynaFuse — Medshape, Inc.
- DynaFuse 5mm Drill — Medshape, Inc.
- DynaNail Helix, Headed, 100mm — Medshape, Inc.
- DynaNail Helix, Headed, 105mm — Medshape, Inc.
- DynaNail Helix, Headed, 110mm — Medshape, Inc.
- DynaNail Helix, Headed, 50mm — Medshape, Inc.
- DynaNail Helix, Headed, 55mm — Medshape, Inc.
- DynaNail Helix, Headed, 60mm — Medshape, Inc.
- DynaNail Helix, Headed, 65mm — Medshape, Inc.
- DynaNail Helix, Headed, 70mm — Medshape, Inc.
- DynaNail Helix, Headed, 75mm — Medshape, Inc.
- DynaNail Helix, Headed, 80mm — Medshape, 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 I | Pending data |
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Manufacturer
- Manufacturer
- Medshape, Inc.
Sources (1)
- FDA UDI 0b72140f-e307-44d5-9a5a-dbe41d19fdcf 33 fields · synced May 30, 2026