Identity
- Trade Name
- OneLIF™ FDA UDI
- Generic Name
- Internal spinal fixation procedure kit, reusable FDA UDI
- Device Name
- Bullet Trial Inserter FDA UDI
- Model / Reference
- 015-040-0000 FDA UDI
- Description
- Bullet Trial Inserter FDA UDI
Identifiers
- Catalog Number
- 015-040-0000 FDA UDI
- Primary DI / UDI-DI
- G07001504000000 FDA UDI
- 510(k) Number
- K211769 FDA UDI
- FDA Product Code
- OVD FDA UDIMAX FDA UDI
- GMDN Term
- Internal spinal fixation procedure kit, 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
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Category: Internal spinal fixation procedure kit, reusable
OneLIF™ by Novapproach Spine — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Internal spinal fixation procedure kit, reusable.
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- Modulus — Nuvasive, Inc. · Class I
- 4CIS® INSTRUMENT SYSTEM — ALPHANOX CO., LTD. · Class I
- NuVasive — Nuvasive, Inc. · Class I
- Zavation — ZAVATION · Class II
- 4CIS® INSTRUMENT SYSTEM — ALPHANOX CO., LTD. · Class I
- ReLine — Nuvasive, Inc. · Class I
- VuePoint — Nuvasive, Inc. · Class I
Cleared under the same submission
K211769 also covers:
- OneLIF™ — Novapproach Spine
- OneLIF™ — Novapproach Spine
- OneLIF™ — Novapproach Spine
- OneLIF™ — Novapproach Spine
- OneLIF™ — Novapproach Spine
- OneLIF™ — Novapproach Spine
- OneLIF™ — Novapproach Spine
- OneLIF™ — Novapproach Spine
- OneLIF™ — Novapproach Spine
- OneLIF™ — Novapproach Spine
- OneLIF™ — Novapproach Spine
- OneLIF™ — Novapproach Spine
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
- Novapproach Spine
Sources (1)
- FDA UDI 2cc64f3a-af4c-4974-8f76-0459dd4f2fac 35 fields · synced Jun 1, 2026