Identity
- Trade Name
- Nex-D2 FDA UDI
- Generic Name
- Bone-screw internal spinal fixation system connector FDA UDI
- Device Name
- SIDE LOADING OFFSET CONNECTOR, 35MM FDA UDI
- Model / Reference
- CBEEJ-55035 FDA UDI
- Description
- SIDE LOADING OFFSET CONNECTOR, 35MM FDA UDI
Identifiers
- Catalog Number
- CBEEJ-55035 FDA UDI
- Primary DI / UDI-DI
- 00840314157027 FDA UDI
- 510(k) Number
- K190981 FDA UDI
- FDA Product Code
- NKB 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 UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
Yes
Contains Latex
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Bone-screw internal spinal fixation system connector
Nex-D2 is a bone-screw internal spinal fixation system designed to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities. This device features a side-loading offset connector, which allows for adjustable length and/or angle, and may also have a small amount of screw/rod movement.
Similar devices
Also classified as Bone-screw internal spinal fixation system connector.
- Arsenal — ALPHATEC SPINE, INC. · Class II
- Zodiac — ALPHATEC SPINE, INC. · Class II
- SOCORE - Spinal Stabilization System — NovaSpine · Class IIb
- LnK Spinal Fixation System — L&K BIOMED CO. , LTD. · Class II
- SOCORE - Spinal Stabilization System — NovaSpine · Class IIb
- APEX Spine System — SPINECRAFT LLC · Class II
- ReLine — Nuvasive, Inc. · Class II
- APEX Spine System — SPINECRAFT LLC · Class II
Cleared under the same submission
K190981 also covers:
- Nex-D2 — Next Orthosurgical
- Nex-D2 — Next Orthosurgical
- Nex-D2 — Next Orthosurgical
- Nex-D2 — Next Orthosurgical
- Nex-D2 — Next Orthosurgical
- Nex-D2 — Next Orthosurgical
- Nex-D2 — Next Orthosurgical
- Nex-D2 — Next Orthosurgical
- Nex-D2 — Next Orthosurgical
- Nex-D2 — Next Orthosurgical
- Nex-D2 — Next Orthosurgical
- Nex-D2 — Next Orthosurgical
Authorization Coverage (1 country)
Regulatory Authorizations
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
- Next Orthosurgical
Sources (1)
- FDA UDI d5155403-1149-4f3f-89e1-d5f8fb3593bf 36 fields · synced Jul 17, 2026