Identity
- Trade Name
- Nautilus NC FDA UDI
- Generic Name
- Bone awl, single-use FDA UDI
- Device Name
- AWL, CONQUEST 2.0 FDA UDI
- Model / Reference
- 148-101 FDA UDI
- Description
- AWL, CONQUEST 2.0 FDA UDI
Identifiers
- Catalog Number
- 148-101 FDA UDI
- Primary DI / UDI-DI
- 00190837087197 FDA UDI
- 510(k) Number
- K111953 FDA UDI
- FDA Product Code
- NKB FDA UDI
- GMDN Term
- Bone awl, single-use 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
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: Bone awl, single-use
Nautilus NC by Life Spine, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Bone awl, single-use.
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Cleared under the same submission
K111953 also covers:
- AVATAR Minimally Invasive Spinal System — Life Spine, Inc.
- AVATAR Minimally Invasive Spinal System — Life Spine, Inc.
- AVATAR Minimally Invasive Spinal System — Life Spine, Inc.
- AVATAR Minimally Invasive Spinal System — Life Spine, Inc.
- AVATAR Minimally Invasive Spinal System — Life Spine, Inc.
- AVATAR Minimally Invasive Spinal System — Life Spine, Inc.
- AVATAR Minimally Invasive Spinal System — Life Spine, Inc.
- AVATAR Minimally Invasive Spinal System — Life Spine, Inc.
- AVATAR Minimally Invasive Spinal System — Life Spine, Inc.
- AVATAR Minimally Invasive Spinal System — Life Spine, Inc.
- AVATAR Minimally Invasive Spinal System — Life Spine, Inc.
- AVATAR Minimally Invasive Spinal System — Life Spine, 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
- Life Spine, Inc.
Sources (1)
- FDA UDI 9a9f767c-9e7c-4030-a055-ff97622f8755 35 fields · synced Jun 8, 2026