Identity
- Trade Name
- Cervical Interbody Fusion Device FDA UDI
- Generic Name
- Surgical implant/trial-implant/sizer holder, reusable FDA UDI
- Device Name
- Cervical Trial 17x10 mm w/Stop FDA UDI
- Model / Reference
- CT1710 FDA UDI
- Description
- Cervical Trial 17x10 mm w/Stop FDA UDI
Identifiers
- Catalog Number
- CT1710 FDA UDI
- Primary DI / UDI-DI
- B565CT17101 FDA UDI
- 510(k) Number
- K123206 FDA UDI
- FDA Product Code
- ODP FDA UDI
- GMDN Term
- Surgical implant/trial-implant/sizer holder, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3080 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
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
- Height — 10 Millimeter FDA UDILength — 17 Millimeter FDA UDI
Category: Surgical implant/trial-implant/sizer holder, reusable
Cervical Interbody Fusion Device by Maxim Surgical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical implant/trial-implant/sizer holder, reusable.
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- JULIET INSTRUMENTATION — Spineart · Class II
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- TALOS® (HA) IBF — MEDITECH SPINE, LLC · Class II
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Cleared under the same submission
K123206 also covers:
- Cervical Interbody Fusion Device — Maxim Surgical
- Cervical Interbody Fusion Device — Maxim Surgical
- Cervical Interbody Fusion Device — Maxim Surgical
- Cervical Interbody Fusion Device — Maxim Surgical
- Cervical Interbody Fusion Device — Maxim Surgical
- Cervical Interbody Fusion Device — Maxim Surgical
- Cervical Interbody Fusion Device — Maxim Surgical
- Cervical Interbody Fusion Device — Maxim Surgical
- Cervical Interbody Fusion Device — Maxim Surgical
- Cervical Interbody Fusion Device — Maxim Surgical
- Cervical Interbody Fusion Device — Maxim Surgical
- Cervical Interbody Fusion Device — Maxim Surgical
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
- Maxim Surgical
Sources (1)
- FDA UDI 1ceb5b93-da7c-4683-899c-df01425ea2f9 37 fields · synced May 30, 2026