Identity
- Trade Name
- Ambassador FDA UDI
- Generic Name
- Spinal intraoperative positioning screw FDA UDI
- Device Name
- Ambassador,Barrel fixation pin,5mm FDA UDI
- Model / Reference
- 05-109-18-0027 FDA UDI
- Description
- Ambassador,Barrel fixation pin,5mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840996183154 FDA UDI
- 510(k) Number
- K143576 FDA UDI
- FDA Product Code
- KQW FDA UDI
- GMDN Term
- Spinal intraoperative positioning screw FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.1520 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: Spinal intraoperative positioning screw
Ambassador by Choicespine, LP — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K143576 also covers:
- AMBASSADOR — Choicespine, LP
- Ambassador — Choicespine, LP
- Ambassador — Choicespine, LP
- Ambassador — Choicespine, LP
- Ambassador Cervical Plate System — Choicespine, LP
- Ambassador Cervical Plate System — Choicespine, LP
- Ambassador Cervical Plate System — Choicespine, LP
- Ambassador Cervical Plate System — Choicespine, LP
- Ambassador Cervical Plate System — Choicespine, LP
- Ambassador Cervical Plate System — Choicespine, LP
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 I | Pending data |
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Manufacturer
- Manufacturer
- Choicespine, LP
Sources (1)
- FDA UDI 16afd9a7-cdbd-4352-954f-f44175d94d0d 35 fields · synced May 30, 2026