Halo Systems
Skull Pin 2-1/4in TI Sterl 1PK
1manufacturer
4catalogue numbers in this listing
1recall
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 | Ossur Americas, United States |
|---|---|
| FDA product code | JEC |
| Device type | Component, Traction, Invasive |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3040 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| 510(k) | K822780 |
| Record published | 2018-05-16 |
| Record revised | 2023-09-18 (version 4) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Distribution end date | 2020-02-28 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 516TS | Withdrawn | |
| 520TS | Withdrawn | |
| 520V2S | Withdrawn | |
| 516V2S | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medline | Medline Industries, Inc. | 115 |
| Fragment Fixation System | Orthofix SRL | 77 |
| Anjon Bremer Halo System | Anjon Holdings, LLC | 68 |
| 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 |
| DigiFix | Virak Orthopedics LLC | 3 |
Showing 12 of 65. All products under Component, Traction, Invasive
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Ossur Americas | 510(k) number | 2018-06-21 | Class II | Labeling design | Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm MR conditional parameters. In addition, the second line description on the titanium pin label mistakenly lists ceramic tip. The second line desc | 372 | 2020-09-04 |
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.