Identity
- Trade Name
- PMT® Halo Systems FDA UDI
- Generic Name
- Cervical spine immobilization system, single-use FDA UDI
- Device Name
- HALO, CTLSO VEST LARGE, COOLMAX LINER, 1211-1 X-LARGE OPEN BACK RING, 1206-20 HEADBLOCKS, 1206-11 TRACTION BAIL FDA UDI
- Model / Reference
- 1214-337 FDA UDI
- Description
- HALO, CTLSO VEST LARGE, COOLMAX LINER, 1211-1 X-LARGE OPEN BACK RING, 1206-20 HEADBLOCKS, 1206-11 TRACTION BAIL FDA UDI
Identifiers
- Catalog Number
- 1214-337 FDA UDI
- Primary DI / UDI-DI
- 00650551116417 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
The PMT Halo Systems are a comprehensive cervical spine immobilization solution designed to protect the neck from injury or surgery. These single-use devices feature a ring around the head, attached to a padded vest and four rods with locking mechanisms, providing stable immobilization. The Halo vest is available in various sizes and can be used by patients in need of temporary support.
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 a862aa1f-887c-44c2-90a2-183004543588 37 fields · synced Jul 8, 2026