Identity
- Trade Name
- MESA® Spinal System FDA UDI
- Generic Name
- Bone-screw internal spinal fixation system hook FDA UDI
- Device Name
- Pedicle Hook Size 10 mm FDA UDI
- Model / Reference
- 801-81003H FDA UDI
- Description
- Pedicle Hook Size 10 mm FDA UDI
Identifiers
- Catalog Number
- 801-81003H FDA UDI
- Primary DI / UDI-DI
- 10888857142893 FDA UDI
- FDA Product Code
- KWQ FDA UDIMNI FDA UDIKWP FDA UDIMNH FDA UDIOSH FDA UDINKB 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 UDI888.3070 FDA UDI888.3050 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
MR Conditional FDA UDI
Dimensions & Sizes
- Size
- Depth — 10 Millimeter FDA UDIWidth — 9 Millimeter FDA UDILength — 10 Millimeter FDA UDIOuter Diameter — 5.5 Millimeter FDA UDI
Category: Bone-screw internal spinal fixation system hook
MESA® Spinal System by K2m, 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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- ReLine — Nuvasive, Inc. · Class II
- COSY — SIGNUS Medizintechnik GmbH · Class II
- neon³™ OCT spinal stabilization — Ulrich GmbH & Co. KG · Class II
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
- K2m, Inc.
Sources (1)
- FDA UDI c7469a95-87ae-4d06-8cac-3cc95f75c2aa 36 fields · synced May 30, 2026