Identity
- Trade Name
- Nautilus Instruments FDA UDI
- Generic Name
- Orthopaedic bone screw starter/notcher FDA UDI
- Device Name
- Hook Starter, Narrow/Reduced Laminar FDA UDI
- Model / Reference
- 116-278 FDA UDI
- Description
- Hook Starter, Narrow/Reduced Laminar FDA UDI
Identifiers
- Catalog Number
- 116-278 FDA UDI
- Primary DI / UDI-DI
- 00190837033415 FDA UDI
- 510(k) Number
- K111953 FDA UDI
- FDA Product Code
- NKB FDA UDI
- GMDN Term
- Orthopaedic bone screw starter/notcher 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: Orthopaedic bone screw starter/notcher
Nautilus Instruments by Life Spine, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic bone screw starter/notcher.
- OsteoMed — Osteomed Corp. · Class II
- ReLine — Nuvasive, Inc. · Class I
- V. Mueller — STERIS CORPORATION · Class I
- V. Mueller — STERIS CORPORATION · Class I
- ReLine — Nuvasive, Inc. · Class I
- Horizon Subtalar Gen 2 Sizing Probe 9mm — BIOPRO, INC. · Class I
- Decima Spine Instrument Kit — DECIMA SPINE, INC. · Class I
- V. Mueller — STERIS CORPORATION · Class I
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 3059649c-1d83-46ee-abfc-6eef5671a27c 35 fields · synced May 30, 2026