Identity
- Trade Name
- PYRAMESH® Implant System FDA UDI
- Generic Name
- Soft-tissue/mesh anchor, non-bioabsorbable FDA UDI
- Device Name
- CYLINDER X110531332 ROUND MESH 13X32 FDA UDI
- Model / Reference
- X110531332 FDA UDI
- Description
- CYLINDER X110531332 ROUND MESH 13X32 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00613994133038 FDA UDI
- 510(k) Number
- K890601 FDA UDI
- FDA Product Code
- EZX FDA UDI
- GMDN Term
- Soft-tissue/mesh anchor, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.3300 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: Soft-tissue/mesh anchor, non-bioabsorbable
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 Soft-tissue/mesh anchor, non-bioabsorbable.
- MectaScrew PEEK — Medacta International · Class II
- MectaFix CL Fixation Button with Continuous Loop — Medacta International · Class II
- HNM MEDICAL — HNM STAINLESS, LLC. · Class II
- MectaLock PEEK Suture Anchor — Medacta International · Class II
- MectaScrew PEEK — Medacta International · Class II
- Anchorsure — DESARROLLO E INVESTIGACION MEDICA ARAGONESA SL · Class II
- FiberStitch™ Implant, Reverse Curve with two Polyester Implants and 2-0 FiberWir — T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION · Class II
- Heli-FX™ Thoracic EndoAnchor™ System — MEDTRONIC VASCULAR, INC. · Class II
Cleared under the same submission
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 052f0c94-4792-40de-9616-5aed35a80126 35 fields · synced May 31, 2026