Identity
- Trade Name
- MESA® Small Stature Spinal System FDA UDI
- Generic Name
- Bone-screw internal spinal fixation system hook FDA UDI
- Device Name
- Offset Laminar Hook, Right Size 7 mm X 8 mm FDA UDI
- Model / Reference
- 3001-80807H FDA UDI
- Description
- Offset Laminar Hook, Right Size 7 mm X 8 mm FDA UDI
Identifiers
- Catalog Number
- 3001-80807H FDA UDI
- Primary DI / UDI-DI
- 10888857389014 FDA UDI
- FDA Product Code
- NKB FDA UDIOSH FDA UDIMNH FDA UDIMNI FDA UDIKWQ FDA UDIKWP FDA UDI
- GMDN Term
- Bone-screw internal spinal fixation system hook FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3070 FDA UDI888.3060 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 — 8 Millimeter FDA UDIWidth — 7 Millimeter FDA UDIOuter Diameter — 5.5 Millimeter FDA UDI
Category: Bone-screw internal spinal fixation system hook
MESA® Small Stature 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 hook.
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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 5cfd0980-2477-4559-b57b-3b4d39724968 36 fields · synced May 31, 2026