Identity
- Trade Name
- Navigational Instruments FDA UDI
- Generic Name
- Surgical screwdriver, reusable FDA UDI
- Device Name
- Navigation Atoll Screwdriver FDA UDI
- Model / Reference
- 77-0018 FDA UDI
- Description
- Navigation Atoll Screwdriver FDA UDI
Identifiers
- Catalog Number
- 77-0018 FDA UDI
- Primary DI / UDI-DI
- 10889981148386 FDA UDI
- 510(k) Number
- K172517 FDA UDI
- FDA Product Code
- OLO FDA UDI
- GMDN Term
- Surgical screwdriver, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.4560 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: Surgical screwdriver, reusable
Navigational Instruments by SeaSpine Orthopedics Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Surgical screwdriver, reusable.
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- USS — Synthes · Class I
- Whistler Modular Pedicle Screw System — EVOLUTION SPINE, LLC · Class I
- CosmoLock Pedicle Screw System — Kalitec Direct LLC · Class I
Cleared under the same submission
K172517 also covers:
- General — SeaSpine Orthopedics Corporation
- General — SeaSpine Orthopedics Corporation
- Navigation Instruments — SeaSpine Orthopedics Corporation
- Navigation Instruments — SeaSpine Orthopedics Corporation
- Navigation Instruments — SeaSpine Orthopedics Corporation
- Navigation Instruments — SeaSpine Orthopedics Corporation
- Navigation Instruments — SeaSpine Orthopedics Corporation
- Navigational Instruments — SeaSpine Orthopedics Corporation
- Navigational Instruments — SeaSpine Orthopedics Corporation
- Navigational Instruments — SeaSpine Orthopedics Corporation
- Navigational Instruments — SeaSpine Orthopedics Corporation
- Special — SeaSpine Orthopedics Corporation
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
- SeaSpine Orthopedics Corporation
Sources (1)
- FDA UDI 8a8cd3d5-3a94-4961-ac74-148929f0b680 36 fields · synced Jun 8, 2026