Identity
- Trade Name
- Latitude-C Cervical Interbody Spacer System FDA UDI
- Generic Name
- Spinal implant trial FDA UDI
- Device Name
- Modular Trial, 14 X 20 X 15, PAR FDA UDI
- Model / Reference
- 03-04T1420 FDA UDI
- Description
- Modular Trial, 14 X 20 X 15, PAR FDA UDI
Identifiers
- Catalog Number
- 03-04T1420 FDA UDI
- Primary DI / UDI-DI
- 00842048125617 FDA UDI
- 510(k) Number
- K151496 FDA UDI
- FDA Product Code
- ODP FDA UDI
- GMDN Term
- Spinal implant trial 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
No
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
- Depth — 14 Millimeter FDA UDIHeight — 14 Millimeter FDA UDIWidth — 18 Millimeter FDA UDI
Category: Spinal implant trial
The Latitude-C Cervical Interbody Spacer System is a modular, 14x20x15 trial device designed for cervical spine fusion. This innovative implant provides a stable and secure environment for bone grafting, allowing surgeons to achieve optimal outcomes in intervertebral fusion procedures.
Similar devices
Also classified as Spinal implant trial.
- Novel — ALPHATEC SPINE, INC. · Class II
- Scarlet AL-T Instruments — Spineart · Class II
- IdentiTi — ALPHATEC SPINE, INC. · Class II
- Anteralign Spinal System with Titan nanoLock Surface technology — MEDTRONIC SOFAMOR DANEK, INC. · Class II
- IdentiTi — ALPHATEC SPINE, INC. · Class II
- MLX — Nuvasive, Inc. · Class I
- IdentiTi — ALPHATEC SPINE, INC. · Class II
- ROI-A — Ldr Spine USA · Class II
Cleared under the same submission
K151496 also covers:
- Latitude-C Cervical Interbody Spacer System — Degen Medical
- Latitude-C Cervical Interbody Spacer System — Degen Medical
- Latitude-C Cervical Interbody Spacer System — Degen Medical
- Latitude-C Cervical Interbody Spacer System — Degen Medical
- Latitude-C Cervical Interbody Spacer System — Degen Medical
- Latitude-C Cervical Interbody Spacer System — Degen Medical
- Latitude-C Cervical Interbody Spacer System — Degen Medical
- Latitude-C Cervical Interbody Spacer System — Degen Medical
- Latitude-C Cervical Interbody Spacer System — Degen Medical
- Latitude-C Cervical Interbody Spacer System — Degen Medical
- Latitude-C Cervical Interbody Spacer System — Degen Medical
- Latitude-C Cervical Interbody Spacer System — Degen Medical
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
- Degen Medical
Sources (1)
- FDA UDI b183fd66-fe4a-4870-9ae2-00466c776d6b 37 fields · synced Jul 12, 2026