Identity
- Trade Name
- Anjon Bremer Halo System FDA UDI
- Generic Name
- Orthopaedic bone pin, non-bioabsorbable FDA UDI
- Device Name
- Anjon Bremer Halo System Traction Set Clamps FDA UDI
- Model / Reference
- Traction set clamp FDA UDI
- Description
- Anjon Bremer Halo System Traction Set Clamps FDA UDI
Identifiers
- Catalog Number
- CLP002AC FDA UDI
- Primary DI / UDI-DI
- 00810592030534 FDA UDI
- 510(k) Number
- K171863 FDA UDI
- FDA Product Code
- JEC FDA UDI
- GMDN Term
- Orthopaedic bone pin, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
Yes
FDA UDI
Category: Orthopaedic bone pin, non-bioabsorbable
Anjon Bremer Halo System by Anjon Holdings, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic bone pin, non-bioabsorbable.
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- XtraFix® External Fixation System — Zimmer, Inc. · Class II
- CALIBRATED GUIDE WIRE, THREADED TROCAR POINT — Biomet Orthopedics, Inc. · Class II
- TRAUMA FIXATION SYSTEMS — Biomet Orthopedics, Inc. · Class II
- SMART TSF — Smith & Nephew, Inc. · Class II
Cleared under the same submission
K171863 also covers:
- Anjon Bremer Halo System — Anjon Holdings, LLC
- Anjon Bremer Halo System — Anjon Holdings, LLC
- Anjon Bremer Halo System — Anjon Holdings, LLC
- Anjon Bremer Halo System — Anjon Holdings, LLC
- Anjon Bremer Halo System — Anjon Holdings, LLC
- Anjon Bremer Halo System — Anjon Holdings, LLC
- Anjon Bremer Halo System — Anjon Holdings, LLC
- Anjon Bremer Halo System — Anjon Holdings, LLC
- Anjon Bremer Halo System — Anjon Holdings, LLC
- Anjon Bremer Halo System — Anjon Holdings, LLC
- Anjon Bremer Halo System — Anjon Holdings, LLC
- Anjon Bremer Halo System — Anjon Holdings, LLC
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
- Anjon Holdings, LLC
Sources (1)
- FDA UDI 3305e9c1-37b4-479e-9b18-437e313f4203 36 fields · synced May 30, 2026