Anjon Bremer Halo System
The Anjon Bremer Halo System immobilizes the cervical spine by fixing the skull relative to the torso. Four titanium skull pins attach to an aluminium crown or ring, which connects through…
The Anjon Bremer Halo System immobilizes the cervical spine by fixing the skull relative to the torso. Four titanium skull pins attach to an aluminium crown or ring, which connects through a rod superstructure to a lined polymer vest.
The ring and frame restrict neck rotation and bending while providing cervical immobilization and therapeutic traction. The vest is one component of this external support arrangement, alongside the skull pins, ring and connecting structure.
Listed Item
Anjon Bremer Halo System Classic Vest, Petite/Slim (160cm and shorter) 26-34 in. (66-86cm)
Surgical Table Configuration
The crown or ring can also connect to a surgical table through a Mayfield adaptor for rigid support during examination or surgery. The ring, rods and skull pins form the mechanical link between the head and either the vest frame or table attachment.
1manufacturer
68catalogue numbers in this listing
2510(k) clearances naming this product code
Who Else Makes It
Registered in Shanghai.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
Record
| Listed by | Anjon Holdings, LLC, United States |
|---|---|
| FDA product code | JEC |
| Device type | Component, Traction, Invasive |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3040 |
| 510(k) | K171863 |
| Record published | 2018-04-20 |
| Record revised | 2025-07-14 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Radiation Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | 3 box shipper of 3, 15 pack box of 15, 3 box shipper of 45, pack of 18, pack of 3, 3-unit shipper of 3 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| Ring Set Accessory Pack | In distribution | ||
| Light Vest, Waist Strap, Short | In distribution | ||
| Small Pediatric Ring Sterile | In distribution | ||
| Light Vest Liner Replacement, Short | In distribution | ||
| Torque Pin Driver, Disposable | In distribution | ||
| 7/16 OPEN END WRENCH | In distribution | ||
| Pediatric Ring, Small, 15-16 in. (38-40cm) | In distribution | ||
| Classic Vest, Petite/Slim (160cm and shorter), 26-34 in. (66-86cm) | In distribution | ||
| Classic Vest Liner Replacement, Large | In distribution | ||
| Torque Pin Driver | In distribution | ||
| Classic Vest Liner Replacement, Petite/Slim | In distribution | ||
| Standard Halo Skull Pins 5 Sterile | In distribution | ||
| Cutting Tip Halo Skull Pins 5 Sterile | In distribution | ||
| Light Vest, Waist Strap, Gray | In distribution | ||
| Light Vest, Short (170cm and shorter), 28-38 in. (72-98cm) | In distribution | ||
| Crown, Large, 23-26 in (58-66cm) | In distribution | ||
| Traction set clamp | In distribution | ||
| Extra Long Halo Skull Pins 2 Sterile | In distribution | ||
| Small Halo Crown Sterile | In distribution | ||
| Pediatric Halo Skull Pins 10 Non-Sterile | In distribution | ||
| Large Pediatric Ring Sterile | In distribution | ||
| “Classic Vest, Large (176cm and taller) 36-42 in. (92-108cm)” | In distribution | ||
| Crown, Small, 19-23 in (48-58cm) | In distribution | ||
| Skull Pin Accessory Pack, Standard 59mm, 10/pk | 10 | In distribution | |
| Light Vest Liner Replacement, Tall | In distribution | ||
| Transverse Bar, 9 inch | In distribution | ||
| Head Positioning Spoon | In distribution | ||
| Pediatric Vest, Child, 22-28 in. (56-72cm) | In distribution | ||
| Pediatric Vest Liner Replacement, Toddler | In distribution | ||
| Mayfield Adaptor Set Ant/Post – Molded Crown | In distribution | ||
| Light Vest, Shoulder Strap | In distribution | ||
| Titanium Torque Driver set | In distribution | ||
| Adjustable Ring, Size B, 19-23 in (48-58cm) | In distribution | ||
| Pediatric Halo Skull Pins 10 Sterile | In distribution | ||
| Skull Pin Accessory Pack, Standard 59mm, 10/pk | 10 | In distribution | |
| Large Adjustable Ring Sterile | In distribution | ||
| Classic Vest, Waist Strap, 22in (56cm) | In distribution | ||
| Molded Halo Crown – Sterile | In distribution | ||
| Extra Long Halo Skull Pins 2 Non-Sterile | In distribution | ||
| Skull Pin, Long 71mm, 2/pk | 2 | In distribution | |
| Classic Vest, Small (176cm and shorter), 32-38 in. (82-98cm) | In distribution | ||
| Mayfield Adaptor Set Ant/Post – Non Sterile | In distribution | ||
| Black Aluminum Wrench, 5 inch | In distribution | ||
| Adjustable Ring , Size C, 21-26 in (56-66cm) | In distribution | ||
| Small Adjustable Ring Sterile | In distribution | ||
| Classic Vest Liner Replacement, Small | In distribution | ||
| Torque Limit Knobs, Red, 28/pk | 28 | In distribution | |
| Torque Limit Knobs, 4/pk | 4 | In distribution | |
| Molded Crown Non-Sterile | In distribution | ||
| Light Vest, Waist Strap, Tall | In distribution | ||
| Torque Limit Knobs, 8/pk | 8 | In distribution | |
| Classic Vest, Waist Strap, 15in (39cm) | In distribution | ||
| Large Halo Crown Sterile | In distribution | ||
| Traction Bale | In distribution | ||
| Classic Vest, Xlarge, 42-58 in. (108-148cm) | In distribution | ||
| Liner Replacement Material | In distribution | ||
| Cutting Tip Halo Skull Pins 5 Non-Sterile | In distribution | ||
| Skull Pin, Standard 59mm, 5/pk | 5 | In distribution | |
| Light Vest, Kyphosis | In distribution | ||
| Crown Set Accessory Pack | In distribution | ||
| Pediatric Vest Liner Replacement, Child | In distribution | ||
| Standard Halo Skull Pins 5 Non-Sterile | In distribution | ||
| Pediatric Ring, Large, 17-19 1/2 in. (43-50cm) | In distribution | ||
| Positioning Pins and Pads, 3/pk | 3 | In distribution | |
| Pediatric Ring Set Accessory Pack | In distribution | ||
| Light Vest, Tall (170cm and taller), 30-44 in. (76-112cm) | In distribution | ||
| Classic Vest Liner Replacement, Xlarge | In distribution | ||
| Pediatric Vest, Toddler, 20-24 in. (50-62cm) | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medline | Medline Industries, Inc. | 115 |
| Fragment Fixation System | Orthofix SRL | 77 |
| Sheffield Ring Fixator | Orthofix SRL | 68 |
| Hoffmann | Stryker GmbH | 65 |
| Hybrid Fixator System | Orthofix SRL | 30 |
| Triax | Stryker GmbH | 26 |
| Bremer | Depuy Spine, Inc. | 11 |
| Additional Accessories FOR THE Orthofix System | Orthofix SRL | 10 |
| Component, Traction, Invasive | Synthes Gmbh | 9 |
| Distraction, Internal | KLS-Martin L.P. | 9 |
| Halo Systems | Ossur Americas | 4 |
| DigiFix | Virak Orthopedics LLC | 3 |
Showing 12 of 65. All products under Component, Traction, Invasive
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K193256 | 2020-03-02 |
| K171863 | 2018-03-19 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.