Identity
- Trade Name
- DynaBridge FDA UDI
- Generic Name
- Cannulated surgical drill bit, single-use, non-sterile FDA UDI
- Device Name
- Calibrated Drill 15mm Length 2.1mm FDA UDI
- Model / Reference
- CD-DB-2015-S FDA UDI
- Description
- Calibrated Drill 15mm Length 2.1mm FDA UDI
Identifiers
- Catalog Number
- CD-DB-2015-S FDA UDI
- Primary DI / UDI-DI
- 00819034023653 FDA UDI
- 510(k) Number
- K181815 FDA UDI
- FDA Product Code
- JDR FDA UDI
- GMDN Term
- Cannulated surgical drill bit, single-use, non-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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Cannulated surgical drill bit, single-use, non-sterile
DynaBridge by Fusion Orthopedics, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Cannulated surgical drill bit, single-use, non-sterile.
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Cleared under the same submission
K181815 also covers:
- DynaBridge — FUSION ORTHOPEDICS, LLC
- DynaBridge — FUSION ORTHOPEDICS, LLC
- DynaBridge — FUSION ORTHOPEDICS, LLC
- DynaBridge — FUSION ORTHOPEDICS, LLC
- DynaBridge — FUSION ORTHOPEDICS, LLC
- DynaBridge — FUSION ORTHOPEDICS, LLC
- DynaBridge — FUSION ORTHOPEDICS, LLC
- DynaBridge — FUSION ORTHOPEDICS, LLC
- DynaBridge — FUSION ORTHOPEDICS, LLC
- DynaBridge — FUSION ORTHOPEDICS, LLC
- DynaBridge — FUSION ORTHOPEDICS, LLC
- DynaBridge — 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 |
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Manufacturer
- Manufacturer
- Fusion Orthopedics, Llc
Sources (1)
- FDA UDI f047c9c4-20f7-4d2a-a8b0-d413513ba7c3 35 fields · synced May 30, 2026