Identity
- Trade Name
- DynaNail Helix, Washer, 15 mm FDA UDI
- Generic Name
- Orthopaedic bone washer, sterile FDA UDI
- Model / Reference
- 3300-00-1515 FDA UDI
Identifiers
- Primary DI / UDI-DI
- M97033000015150 FDA UDI
- 510(k) Number
- K203595 FDA UDI
- FDA Product Code
- HTN FDA UDI
- GMDN Term
- Orthopaedic bone washer, sterile FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3030 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Orthopaedic bone washer, sterile
DynaNail Helix, Washer, 15 mm by Medshape, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic bone washer, sterile.
- BITE COMPRESSION SCREWS — Orthofix, Inc. · Class II
- TELEGRAPH® EVOLUTION Humeral Nailing System — FOURNITURES HOSPITALIERES INDUSTRIE · Class II
- TELEGRAPH® EVOLUTION Humeral Nailing System — FOURNITURES HOSPITALIERES INDUSTRIE · Class II
- FLAT WASHER6.5MM — Biomet Orthopedics, Inc. · Class II
- TELEGRAPH® EVOLUTION Humeral Nailing System — FOURNITURES HOSPITALIERES INDUSTRIE · Class II
- RONDO' — Citieffe · Class II
- SURFIX — Newdeal Sas · Class II
- SURFIX — Newdeal Sas · Class II
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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medshape, Inc.
Sources (1)
- FDA UDI 4e8e2227-6874-48de-aa6f-46981ec50b23 33 fields · synced Jun 8, 2026