Identity
- Trade Name
- PYRAMESH® Implant System FDA UDI
- Generic Name
- Extra-gynaecological surgical mesh, metal FDA UDI
- Device Name
- MESH 905-108 PYRM 10MM X 8MM ROUND FDA UDI
- Model / Reference
- 905-108 FDA UDI
- Description
- MESH 905-108 PYRM 10MM X 8MM ROUND FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00763000855291 FDA UDI
- FDA Product Code
- EZX FDA UDIMQP FDA UDI
- GMDN Term
- Extra-gynaecological surgical mesh, metal FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.3300 FDA UDI888.3060 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Extra-gynaecological surgical mesh, metal
PYRAMESH® Implant System by Medtronic Sofamor Danek, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Extra-gynaecological surgical mesh, metal.
- ACE — ACE SURGICAL SUPPLY CO., INC. · Class II
- OSSEOGUARD® — BIOMET 3I, LLC · Class II
- i-Clean Excellent Solid Abutment Healing Cap — DENTIS CO. , LTD · Class II
- X-Change — Howmedica Osteonics Corp. · Class II
- i-Clean Excellent Solid Abutment Healing Cap — DENTIS CO. , LTD · Class II
- ACE — ACE SURGICAL SUPPLY CO., INC. · Class II
- Medicon — Medicon eG. Chirurgiemechaniker-Genossenschaft · Class II
- Medicon — Medicon eG. Chirurgiemechaniker-Genossenschaft · Class II
Cleared under the same submission
K183197 also covers:
- PYRAMESH® C Titanium Mesh — MEDTRONIC SOFAMOR DANEK, INC.
- PYRAMESH® C Titanium Mesh — MEDTRONIC SOFAMOR DANEK, INC.
- PYRAMESH® C Titanium Mesh — MEDTRONIC SOFAMOR DANEK, INC.
- PYRAMESH® C Titanium Mesh — MEDTRONIC SOFAMOR DANEK, INC.
- PYRAMESH® C Titanium Mesh — MEDTRONIC SOFAMOR DANEK, INC.
- PYRAMESH® Implant System — MEDTRONIC SOFAMOR DANEK, INC.
- PYRAMESH® Implant System — MEDTRONIC SOFAMOR DANEK, INC.
- PYRAMESH® Implant System — MEDTRONIC SOFAMOR DANEK, INC.
- PYRAMESH® Implant System — MEDTRONIC SOFAMOR DANEK, INC.
- PYRAMESH® Implant System — MEDTRONIC SOFAMOR DANEK, INC.
- PYRAMESH® Implant System — MEDTRONIC SOFAMOR DANEK, INC.
- PYRAMESH® Implant System — MEDTRONIC SOFAMOR DANEK, INC.
K890601 also covers:
- CD HORIZON® Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- CD HORIZON® Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- PYRAMESH® C Titanium Mesh — MEDTRONIC SOFAMOR DANEK, INC.
- PYRAMESH® Implant System — MEDTRONIC SOFAMOR DANEK, INC.
- PYRAMESH® Implant System — MEDTRONIC SOFAMOR DANEK, INC.
- PYRAMESH® Implant System — MEDTRONIC SOFAMOR DANEK, INC.
- PYRAMESH® Implant System — MEDTRONIC SOFAMOR DANEK, INC.
- PYRAMESH® Implant System — MEDTRONIC SOFAMOR DANEK, INC.
- PYRAMESH® Implant System — MEDTRONIC SOFAMOR DANEK, INC.
- PYRAMESH® Implant System — MEDTRONIC SOFAMOR DANEK, INC.
- PYRAMESH® Implant System — MEDTRONIC SOFAMOR DANEK, INC.
- PYRAMESH® Implant System — MEDTRONIC SOFAMOR DANEK, 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
- Medtronic Sofamor Danek, Inc.
Sources (1)
- FDA UDI 732f085a-d885-4405-a69f-8e4973513fe5 35 fields · synced Jun 1, 2026