Identity
- Trade Name
- PMT CORPORATION HALO FDA UDI
- Generic Name
- Cervical spine immobilization system, single-use FDA UDI
- Device Name
- BLACK KNOB FOR SURGICAL BED ADAPTER FDA UDI
- Model / Reference
- 1201-62 FDA UDI
- Description
- BLACK KNOB FOR SURGICAL BED ADAPTER FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00650551146407 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
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Conditional FDA UDI
Category: Cervical spine immobilization system, single-use
Pmt Corporation Halo by Pmt Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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:
- HALO VEST LINER — 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
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
- Pmt Corp.
Sources (1)
- FDA UDI 081c96e2-3cd2-419f-a6fd-0f50041006e6 34 fields · synced May 30, 2026