Identity
- Trade Name
- PYRAMESH® Implant System FDA UDI
- Generic Name
- Bone-screw internal spinal fixation system hook FDA UDI
- Device Name
- MESH 905-166 PYRM 16MM X 60MM ROUND FDA UDI
- Model / Reference
- 905-166 FDA UDI
- Description
- MESH 905-166 PYRM 16MM X 60MM ROUND FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00763000855383 FDA UDI
- 510(k) Number
- K011406 FDA UDI
- FDA Product Code
- MQP FDA UDI
- GMDN Term
- Bone-screw internal spinal fixation system hook FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3060 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
Category: Bone-screw internal spinal fixation system hook
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 Bone-screw internal spinal fixation system hook.
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- Medyssey Spinal System - Deformity — Medyssey Co., Ltd. · Class II
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- MESA® Small Stature Spinal System — K2M, INC. · Class II
- ReLine — Nuvasive, Inc. · Class II
- MESA® Small Stature Spinal System — K2M, INC. · Class II
- COSY — SIGNUS Medizintechnik GmbH · Class II
Cleared under the same submission
K011406 also covers:
- CD HORIZON® Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- CD HORIZON® Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- CD HORIZON® Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- 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® 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® C Titanium Mesh — 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 |
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Manufacturer
- Manufacturer
- Medtronic Sofamor Danek, Inc.
Sources (1)
- FDA UDI d01cc9c5-0ba0-494d-8f60-2df31775ade6 35 fields · synced Jun 8, 2026