Identity
- Trade Name
- Simplify® Cervical Artificial Disc FDA UDI
- Generic Name
- Spinal implant trial FDA UDI
- Device Name
- Simplify® Trial, Size LG, Height 6, 5° Lordosis FDA UDI
- Model / Reference
- E FDA UDI
- Description
- Simplify® Trial, Size LG, Height 6, 5° Lordosis FDA UDI
Identifiers
- Catalog Number
- T-LG-6L FDA UDI
- Primary DI / UDI-DI
- 00843285100771 FDA UDI
- PMA Number
- P200022 FDA UDI
- FDA Product Code
- MJO FDA UDI
- GMDN Term
- Spinal implant trial FDA UDI
Classification
- Device Class
- Class III 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
- Height — 6 Millimeter FDA UDIAngle — 5 degree FDA UDI
Category: Spinal implant trial
Simplify® Cervical Artificial Disc by Nuvasive, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Spinal implant trial.
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- IdentiTi — ALPHATEC SPINE, INC. · Class II
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- ROI-A — Ldr Spine USA · Class II
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Cleared under the same submission
P200022 also covers:
- Simplify — Nuvasive, Inc.
- Simplify — Nuvasive, Inc.
- Simplify — Nuvasive, Inc.
- Simplify — Nuvasive, Inc.
- Simplify — Nuvasive, Inc.
- Simplify — Nuvasive, Inc.
- Simplify — Nuvasive, Inc.
- Simplify — Nuvasive, Inc.
- Simplify — Nuvasive, Inc.
- Simplify — Nuvasive, Inc.
- Simplify — Nuvasive, Inc.
- Simplify — Nuvasive, Inc.
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 III | Pending data |
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Manufacturer
- Manufacturer
- Nuvasive, Inc.
Sources (1)
- FDA UDI 9935aa8e-c928-4fc5-a820-4ed7f6d09ad1 37 fields · synced Jun 1, 2026