Identity
- Trade Name
- DynaBridge FDA UDI
- Generic Name
- Surgical drill guide, single-use FDA UDI
- Device Name
- Calc Slide Drill Guide 8mm (Sterile) FDA UDI
- Model / Reference
- CD-DB-CG08-S FDA UDI
- Description
- Calc Slide Drill Guide 8mm (Sterile) FDA UDI
Identifiers
- Catalog Number
- CD-DB-CG08-S FDA UDI
- Primary DI / UDI-DI
- 00840124514584 FDA UDI
- 510(k) Number
- K181815 FDA UDI
- FDA Product Code
- LXI FDA UDI
- GMDN Term
- Surgical drill guide, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4820 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: Surgical drill guide, single-use
DynaBridge by Fusion Orthopedics, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Surgical drill guide, single-use.
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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 I | Pending data |
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Manufacturer
- Manufacturer
- Fusion Orthopedics, Llc
Sources (1)
- FDA UDI d5c76d22-c38b-45fb-94a2-76ef71193b93 35 fields · synced May 30, 2026