Ligapass
Ligapass Connector With Parallel Lockings
1manufacturer
20catalogue numbers in this listing
5510(k) clearances naming this product code
1recall
Who Else Makes It
Registered in Shandong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
Record
| Listed by | Medicrea International, France |
|---|---|
| FDA product code | OWI |
| Device type | Bone Fixation Cerclage, Sublaminar |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3010 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K132395 |
| Record published | 2017-01-27 |
| Record revised | 2024-02-19 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Distribution end date | 2023-03-24 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| B08106035S | In distribution | |
| B08106040S | In distribution | |
| B08106005S | In distribution | |
| B08110005 | In distribution | |
| B08110010 | In distribution | |
| B08116040S | In distribution | |
| B19134550S | Withdrawn | |
| B08106010 | Withdrawn | |
| B08106040 | Withdrawn | |
| B19134550 | Withdrawn | |
| B08100010 | Withdrawn | |
| B08100005 | Withdrawn | |
| B08100001 | Withdrawn | |
| B08116040 | Withdrawn | |
| B08116035 | Withdrawn | |
| B08106005 | Withdrawn | |
| B08116035S | Withdrawn | |
| B08106035 | Withdrawn | |
| B08106025 | Withdrawn | |
| B08106001 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Jazz System | Implanet | 118 |
| Hiline | Globus Medical, Inc. | 22 |
| Translace™ Spinal Tethering System | Medtronic Sofamor Danek, Inc. | 14 |
| Nile™ Alternative Fixation System | VB Spine LLC | 13 |
| Nile™ Proximal Fixation System | VB Spine LLC | 13 |
| Universal Clamp ™ | Zimmer Spine, Inc. | 9 |
| VersaTie | Nuvasive, Inc. | 8 |
| Silc | Globus Medical, Inc. | 8 |
| Mariner Cap | Seaspine Orthopedics Corporation | 7 |
| Jazz Lock | Implanet | 6 |
| Invictus | Alphatec Spine, Inc. | 5 |
| Karma | Spinal Elements, Inc. | 3 |
Showing 12 of 20. All products under Bone Fixation Cerclage, Sublaminar
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K213659 | 2022-05-24 |
| K173506 | 2018-04-03 |
| K172021 | 2017-08-30 |
| K160698 | 2016-09-02 |
| K132395 | 2013-12-06 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2020-10-08 | Class II | Device Design | Tightening the LIGAPASS Band with this instrument, the tensioner’s pliers can crush the band causing the band to break during surgery and lead to a risk of infection and re-intervention , | 17 units US; 8 units OUS Expanded: 1 US and 3 OUS | 2024-05-09 |
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.