Identity
- Trade Name
- MESA® Small Stature Spinal System FDA UDI
- Generic Name
- Bone-screw internal spinal fixation system hook FDA UDI
- Device Name
- Pedicle Hook Size (M) FDA UDI
- Model / Reference
- 3001-80603 FDA UDI
- Description
- Pedicle Hook Size (M) FDA UDI
Identifiers
- Catalog Number
- 3001-80603 FDA UDI
- Primary DI / UDI-DI
- 10888857052062 FDA UDI
- FDA Product Code
- OSH FDA UDIKWP FDA UDIKWQ FDA UDIMNI FDA UDIMNH FDA UDINKB FDA UDI
- GMDN Term
- Bone-screw internal spinal fixation system hook FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3070 FDA UDI888.3050 FDA UDI888.3060 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
Moist Heat or Steam Sterilization FDA UDI
MR Conditional FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 4.5 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
Similar devices
Also classified as Bone-screw internal spinal fixation system hook.
- PERLA ® TL — Spineart · Class II
- Medyssey Spinal System - Deformity — Medyssey Co., Ltd. · Class II
- CD HORIZON® Spinal System — MEDTRONIC SOFAMOR DANEK, INC. · Class II
- PASS LP PASS TL — Medicrea International SA · Class II
- TSRH® Spinal System — MEDTRONIC SOFAMOR DANEK, INC. · Class II
- 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- K2m, Inc.
Sources (1)
- FDA UDI 98a3fa5d-885b-47ca-94f0-1f1ba1dca478 36 fields · synced Jun 8, 2026