Identity
- Trade Name
- MESA® Spinal System FDA UDI
- Generic Name
- Bone-screw internal spinal fixation system connector FDA UDI
- Device Name
- Lateral Offset Conn, Down Size 30°x25 mm, MESA Rai FDA UDI
- Model / Reference
- 801-75525H-D30 FDA UDI
- Description
- Lateral Offset Conn, Down Size 30°x25 mm, MESA Rai FDA UDI
Identifiers
- Catalog Number
- 801-75525H-D30 FDA UDI
- Primary DI / UDI-DI
- 10888857142220 FDA UDI
- FDA Product Code
- MNI FDA UDIOSH FDA UDIKWP FDA UDINKB FDA UDIMNH FDA UDI
- GMDN Term
- Bone-screw internal spinal fixation system connector FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3070 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
Dimensions & Sizes
- Size
- Length — 25 Millimeter FDA UDIAngle — 30 degree FDA UDIOuter Diameter — 5.5 Millimeter FDA UDI
Category: Bone-screw internal spinal fixation system connector
MESA® Spinal System by K2m, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Bone-screw internal spinal fixation system connector.
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- APEX Spine System — SPINECRAFT LLC · 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 a9db6d6b-e5e0-4a89-adea-9a36b97e0abf 36 fields · synced Jun 8, 2026