Identity
- Trade Name
- PMT® Halo Systems FDA UDI
- Generic Name
- Cervical spine immobilization system, single-use FDA UDI
- Device Name
- HALO, 1203-9 VEST MEDIUM, ACRYLIC LINER, 1201-1 MEDIUM CLOSED BACK RING, 1206-25 HEADBLOCKS, W/ NO TRACTION BAIL FDA UDI
- Model / Reference
- 1218-027 FDA UDI
- Description
- HALO, 1203-9 VEST MEDIUM, ACRYLIC LINER, 1201-1 MEDIUM CLOSED BACK RING, 1206-25 HEADBLOCKS, W/ NO TRACTION BAIL FDA UDI
Identifiers
- Catalog Number
- 1218-027 FDA UDI
- Primary DI / UDI-DI
- 00650551103776 FDA UDI
- 510(k) Number
- K090733 FDA UDI
- FDA Product Code
- HAX FDA UDI
- GMDN Term
- Cervical spine immobilization system, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.5960 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
Yes
Contains Latex
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Cervical spine immobilization system, single-use
This Cervical Spine Immobilization System, PMT Halo Systems, is a single-use, implantable device designed to provide stable and secure cervical spine immobilization for patients after injury or surgery. The device consists of a ring(s) around the head (the halo), attached to the skull with threaded bolts, along with instrumentation for precise positioning and stabilization.
Similar devices
Also classified as Cervical spine immobilization system, single-use.
- Sterile and Non Sterile Spinal System — Shandong Weigao Orthopaedic Device Company Limited. · Class IIb
- SKYLINE ANTERIOR CERVICAL PLATE SYSTEM — MEDOS INTERNATIONAL SARL · Class IIb
- SYMPHONY OCT SYSTEM — MEDOS INTERNATIONAL SARL · Class IIb
- MATRIS - Cervical plates and screw — NovaSpine · Class IIb
- PCF Rod — Shandong Weigao Orthopaedic Device Company Limited. · Class IIb
- TST Spinal System — TST RAKOR VE TIBBİ ALETLER SAN.VE TİC.LTD.ŞTİ. · Class IIb
- SYMPHONY OCT SYSTEM — MEDOS INTERNATIONAL SARL · Class IIb
- JQL-III Screw 20mm (sterile) — Chongqing FWS Medical Device Co.,Ltd · Class IIb
Cleared under the same submission
K090733 also covers:
- PMT CORPORATION HALO — Pmt Corp.
- PMT® CORPORATION HALO — Pmt Corp.
- PMT® CORPORATION HALO — Pmt Corp.
- PMT® CORPORATION HALO — Pmt Corp.
- PMT® CORPORATION HALO — Pmt Corp.
- PMT® CORPORATION HALO — Pmt Corp.
- PMT® CORPORATION HALO — Pmt Corp.
- PMT® CORPORATION HALO — Pmt Corp.
- PMT® CORPORATION HALO — Pmt Corp.
- PMT® CORPORATION HALO — Pmt Corp.
- PMT® CORPORATION HALO — Pmt Corp.
- PMT® CORPORATION HALO — Pmt Corp.
Authorization Coverage (1 country)
Regulatory Authorizations
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
- Pmt Corp.
Sources (1)
- FDA UDI 1e051c45-2a88-481a-a162-358a77f14de1 37 fields · synced Jul 29, 2026