Identity
- Trade Name
- Admiral FDA UDI
- Generic Name
- Surgical drill guide, reusable FDA UDI
- Device Name
- Lateral DTS Guide, 0 Deg FDA UDI
- Model / Reference
- AP2-100120 FDA UDI
- Description
- Lateral DTS Guide, 0 Deg FDA UDI
Identifiers
- Catalog Number
- AP2-100120 FDA UDI
- Primary DI / UDI-DI
- 10889981276836 FDA UDI
- 510(k) Number
- K212139 FDA UDI
- FDA Product Code
- KWQ FDA UDI
- GMDN Term
- Surgical drill guide, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3060 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 drill guide, reusable
Admiral by SeaSpine Orthopedics Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical drill guide, reusable.
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Cleared under the same submission
K212139 also covers:
- Admiral — SeaSpine Orthopedics Corporation
- Admiral — SeaSpine Orthopedics Corporation
- Admiral — SeaSpine Orthopedics Corporation
- Admiral — SeaSpine Orthopedics Corporation
- Admiral — SeaSpine Orthopedics Corporation
- Admiral — SeaSpine Orthopedics Corporation
- Admiral — SeaSpine Orthopedics Corporation
- Admiral — SeaSpine Orthopedics Corporation
- Admiral — SeaSpine Orthopedics Corporation
- Admiral — SeaSpine Orthopedics Corporation
- Admiral — SeaSpine Orthopedics Corporation
- Admiral — 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 d8a6e709-b607-4a88-80e0-4343ffddce8a 36 fields · synced Jun 8, 2026