Identity
- Trade Name
- DynaBridge FDA UDI
- Generic Name
- Surgical saw blade, sagittal, single-use FDA UDI
- Device Name
- YOCO Blade Akin (Single) 3mm FDA UDI
- Model / Reference
- CD-OP-1003-S1 FDA UDI
- Description
- YOCO Blade Akin (Single) 3mm FDA UDI
Identifiers
- Catalog Number
- CD-OP-1003-S1 FDA UDI
- Primary DI / UDI-DI
- 00819034027002 FDA UDI
- 510(k) Number
- K181815 FDA UDI
- FDA Product Code
- HSO FDA UDI
- GMDN Term
- Surgical saw blade, sagittal, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 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
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
Moist Heat or Steam Sterilization FDA UDI
Category: Surgical saw blade, sagittal, single-use
DynaBridge by Fusion Orthopedics, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical saw blade, sagittal, single-use.
- IMEDICOM SAW BLADE — IMEDICOM CO., LTD. · Class I
- De Soutter Medical — De Soutter Medical, Ltd. · Class I
- Competitive Oscillating Saw Blade for ConMed®/Linvatec® Hall® — Gebr. Brasseler GmbH & Co. KG · Class I
- Stryker Performance Series — Stryker Corp. · Class I
- IMEDICOM SAW BLADE — IMEDICOM CO., LTD. · Class I
- Competitive Oscillating Saw Blade for ConMed®/Linvatec® Hall® — Gebr. Brasseler GmbH & Co. KG · Class I
- IMEDICOM SAW BLADE — IMEDICOM CO., LTD. · Class I
- IMEDICOM SAW BLADE — IMEDICOM CO., LTD. · Class I
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 1e00d61d-915f-4da2-8309-1f641a45d35a 35 fields · synced May 30, 2026