Identity
- Trade Name
- Anjon Bremer Halo System FDA UDI
- Generic Name
- Orthopaedic bone pin, non-bioabsorbable FDA UDI
- Device Name
- Anjon Bremer Halo System, Pediatric Halo Skull Pins 10 Non-Sterile FDA UDI
- Model / Reference
- Pediatric Halo Skull Pins 10 Non-Sterile FDA UDI
- Description
- Anjon Bremer Halo System, Pediatric Halo Skull Pins 10 Non-Sterile FDA UDI
Identifiers
- Catalog Number
- 100017 FDA UDI
- Primary DI / UDI-DI
- 00810592030497 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
Moist Heat or Steam Sterilization FDA UDI
MR Conditional 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 eca6fcbd-d5de-4c62-83b2-0086d0635f6d 36 fields · synced May 30, 2026