Identity
- Trade Name
- Modulus Expandable FDA UDI
- Generic Name
- Internal spinal fixation procedure kit, reusable FDA UDI
- Device Name
- MOD-EX XLIF Expansion Driver FDA UDI
- Model / Reference
- 1970005 FDA UDI
- Description
- MOD-EX XLIF Expansion Driver FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00195377042132 FDA UDI
- 510(k) Number
- K220478 FDA UDI
- FDA Product Code
- OVD FDA UDIMQV FDA UDIMAX FDA UDIPHM FDA UDI
- GMDN Term
- Internal spinal fixation procedure kit, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3080 FDA UDI888.3045 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
Category: Internal spinal fixation procedure kit, reusable
Modulus Expandable by Nuvasive, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Internal spinal fixation procedure kit, reusable.
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- Zavation — ZAVATION · Class II
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Cleared under the same submission
K220478 also covers:
- Modulus Expandable — Nuvasive, Inc.
- Modulus Expandable — Nuvasive, Inc.
- Modulus Expandable — Nuvasive, Inc.
- Modulus Expandable — Nuvasive, Inc.
- Modulus Expandable — Nuvasive, Inc.
- Modulus Expandable — Nuvasive, Inc.
- Modulus Expandable — Nuvasive, Inc.
- Modulus Expandable — Nuvasive, Inc.
- Modulus Expandable — Nuvasive, Inc.
- Modulus Expandable — Nuvasive, Inc.
- Modulus Expandable — Nuvasive, Inc.
- Modulus Expandable — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Nuvasive, Inc.
Sources (1)
- FDA UDI 5e5f374a-3d89-40d5-bf8a-d86a19c1c970 35 fields · synced May 30, 2026