Transition
TRANSITION 6.5mm HA 1.0mm Step Dual Outer Diameter Screw, 50mm
4manufacturers in China registered for this device type
278catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Jiangsu (2), Shanghai (1), Shandong (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| APS Materials Suzhou | Suzhou | Jiangsu | Contract manufacturer | 18 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
Record
| Listed by | Globus Medical, Inc., United States |
|---|---|
| FDA product code | NQP |
| Device type | Posterior Metal/Polymer Spinal System, Fusion |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Establishment | Manufacturer, Exporter |
| 510(k) | K073439 |
| Record published | 2015-11-06 |
| Record revised | 2025-07-02 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
| Sizes | Length 8 to 500 mm; outer diameter 5.5 to 8.5 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 152.075S | Outer Diameter 5.5 mm | In distribution |
| 152.465S | Length 45 mm | In distribution |
| 152.612S | Length 22 mm | In distribution |
| 152.764S | Outer Diameter 7.5 mm | In distribution |
| 152.763S | Length 35 mm | In distribution |
| 152.555S | Length 60 mm | In distribution |
| 152.789S | Length 65 mm | In distribution |
| 152.524S | Outer Diameter 7 mm | In distribution |
| 152.020S | Length 30 mm | In distribution |
| 152.122S | Outer Diameter 5.5 mm | In distribution |
| 152.843S | Outer Diameter 6.5 mm | In distribution |
| 152.803S | Length 40 mm | In distribution |
| 152.569S | Outer Diameter 7.5 mm | In distribution |
| 152.614S | Outer Diameter 5.5 mm | In distribution |
| 152.610S | Outer Diameter 5.5 mm | In distribution |
| 152.708S | Length 70 mm | In distribution |
| 152.713S | Length 95 mm | In distribution |
| 152.509S | Length 75 mm | In distribution |
| 152.052S | Length 32 mm | In distribution |
| 152.581S | Length 40 mm | In distribution |
| 152.363S | Length 35 mm | In distribution |
| 152.383S | Outer Diameter 8.5 mm | In distribution |
| 152.048S | Length 28 mm | In distribution |
| 152.468S | Outer Diameter 6.5 mm | In distribution |
| 152.530S | Outer Diameter 7 mm | In distribution |
| 152.379S | Outer Diameter 7.5 mm | In distribution |
| 152.128S | Outer Diameter 5.5 mm | In distribution |
| 152.110S | Length 20 mm | In distribution |
| 152.616S | Length 26 mm | In distribution |
| 152.152S | Outer Diameter 5.5 mm | In distribution |
| 152.485S | Outer Diameter 8.5 mm | In distribution |
| 152.510S | Length 80 mm | In distribution |
| 152.589S | Length 80 mm | In distribution |
| 152.046S | Length 26 mm | In distribution |
| 152.774S | Length 40 mm | In distribution |
| 152.526S | Length 65 mm | In distribution |
| 452.022S | Length 22 mm | In distribution |
| 152.768S | Outer Diameter 7.5 mm | In distribution |
| 152.826S | Length 65 mm | In distribution |
| 152.018S | Length 28 mm | In distribution |
| 152.804S | Outer Diameter 6.5 mm | In distribution |
| 152.463S | Outer Diameter 6.5 mm | In distribution |
| 152.568S | Length 50 mm | In distribution |
| 152.072S | Outer Diameter 5.5 mm | In distribution |
| 152.366S | Length 50 mm | In distribution |
| 152.469S | Outer Diameter 6.5 mm | In distribution |
| 152.377S | Outer Diameter 7.5 mm | In distribution |
| 152.484S | Length 40 mm | In distribution |
| 152.720S | Length 35 mm | In distribution |
| 152.582S | Outer Diameter 8.5 mm | In distribution |
| 152.082S | Outer Diameter 5.5 mm | In distribution |
| 152.572S | Outer Diameter 7.5 mm | In distribution |
| 152.618S | Outer Diameter 5.5 mm | In distribution |
| 152.777S | Length 55 mm | In distribution |
| 152.080S | Length 35 mm | In distribution |
| 152.387S | Length 55 mm | In distribution |
| 152.388S | Outer Diameter 8.5 mm | In distribution |
| 152.586S | Length 65 mm | In distribution |
| 152.528S | Length 75 mm | In distribution |
| 152.464S | Length 40 mm | In distribution |
| 152.078S | Outer Diameter 5.5 mm | In distribution |
| 452.028S | Length 28 mm | In distribution |
| 152.062S | Outer Diameter 5.5 mm | In distribution |
| 152.565S | Length 35 mm | In distribution |
| 152.024S | Length 34 mm | In distribution |
| 452.014S | Length 14 mm | In distribution |
| 152.492S | Length 80 mm | In distribution |
| 152.384S | Outer Diameter 8.5 mm | In distribution |
| 152.727S | Outer Diameter 7 mm | In distribution |
| 152.000 | In distribution | |
| 152.200 | In distribution | |
| 152.773S | Length 35 mm | In distribution |
| 152.703S | Length 45 mm | In distribution |
| 152.725S | Outer Diameter 7 mm | In distribution |
| 152.158S | Length 38 mm | In distribution |
| 452.010S | Length 10 mm | In distribution |
| 152.042S | Length 22 mm | In distribution |
| 152.628S | Length 38 mm | In distribution |
| 152.785S | Length 45 mm | In distribution |
| 152.630S | Outer Diameter 5.5 mm | In distribution |
| 152.374S | Length 40 mm | In distribution |
| 152.584S | Length 55 mm | In distribution |
| 152.386S | Length 50 mm | In distribution |
| 152.504S | Outer Diameter 6.5 mm | In distribution |
| 152.802S | Outer Diameter 6.5 mm | In distribution |
| 452.024S | Length 24 mm | In distribution |
| 152.016S | Outer Diameter 5.5 mm | In distribution |
| 152.523S | Length 50 mm | In distribution |
| 152.814S | Outer Diameter 7.5 mm | In distribution |
| 152.570S | Outer Diameter 7.5 mm | In distribution |
| 152.626S | Outer Diameter 5.5 mm | In distribution |
| 152.553S | Length 50 mm | In distribution |
| 152.520S | Length 35 mm | In distribution |
| 152.729S | Outer Diameter 7 mm | In distribution |
| 152.478S | Outer Diameter 7.5 mm | In distribution |
| 152.088S | Outer Diameter 5.5 mm | In distribution |
| 152.512S | Outer Diameter 6.5 mm | In distribution |
| 152.533S | Length 100 mm | In distribution |
| 152.622S | Length 32 mm | In distribution |
| 152.531S | Outer Diameter 7 mm | In distribution |
| 152.090S | In distribution | |
| 152.788S | Length 60 mm | In distribution |
| 152.733S | Outer Diameter 7 mm | In distribution |
| 152.032S | Length 42 mm | In distribution |
| 152.373S | Length 35 mm | In distribution |
| 152.481S | Length 75 mm | In distribution |
| 152.529S | Length 80 mm | In distribution |
| 152.126S | Length 36 mm | In distribution |
| 152.120S | Length 30 mm | In distribution |
| 152.554S | Length 55 mm | In distribution |
| 152.576S | Length 90 mm | In distribution |
| 452.030S | Length 30 mm | In distribution |
| 152.841S | Outer Diameter 6.5 mm | In distribution |
| 152.156S | Length 36 mm | In distribution |
| 152.210 | In distribution | |
| 152.073S | Length 100 mm | In distribution |
| 152.724S | Outer Diameter 7 mm | In distribution |
| 152.591S | Length 90 mm | In distribution |
| 152.482S | Length 80 mm | In distribution |
| 152.779S | Outer Diameter 7.5 mm | In distribution |
| 152.790S | Length 70 mm | In distribution |
| 152.707S | Length 65 mm | In distribution |
| 152.095S | In distribution | |
| 152.845S | Length 60 mm | In distribution |
| 152.726S | Outer Diameter 7 mm | In distribution |
| 152.590S | Outer Diameter 8.5 mm | In distribution |
| 152.787S | Length 55 mm | In distribution |
| 152.728S | Length 75 mm | In distribution |
| 152.083S | Length 100 mm | In distribution |
| 152.202 | In distribution | |
| 152.475S | Length 45 mm | In distribution |
| 152.571S | Length 65 mm | In distribution |
| 152.585S | Length 60 mm | In distribution |
| 152.162S | Length 42 mm | In distribution |
| 452.018S | Length 18 mm | In distribution |
| 152.775S | Length 45 mm | In distribution |
| 152.369S | Length 65 mm | In distribution |
| 152.480S | Length 70 mm | In distribution |
| 152.144S | Length 24 mm | In distribution |
| 152.786S | Length 50 mm | In distribution |
| 152.473S | Length 35 mm | In distribution |
| 152.503S | Length 45 mm | In distribution |
| 152.502S | Length 40 mm | In distribution |
| 152.368S | Length 60 mm | In distribution |
| 152.709S | Length 75 mm | In distribution |
| 152.769S | Length 65 mm | In distribution |
| 152.474S | Outer Diameter 7.5 mm | In distribution |
| 152.587S | Outer Diameter 8.5 mm | In distribution |
| 452.012S | Length 12 mm | In distribution |
| 152.821S | Length 40 mm | In distribution |
| 152.730S | Length 85 mm | In distribution |
| 152.010S | Length 20 mm | In distribution |
| 152.085S | Length 150 mm | In distribution |
| 152.813S | Outer Diameter 7.5 mm | In distribution |
| 152.507S | Outer Diameter 6.5 mm | In distribution |
| 152.118S | Length 28 mm | In distribution |
| 152.731S | Outer Diameter 7 mm | In distribution |
| 152.705S | Outer Diameter 6.5 mm | In distribution |
| 152.704S | Outer Diameter 6.5 mm | In distribution |
| 152.846S | Outer Diameter 6.5 mm | In distribution |
| 152.722S | Length 45 mm | In distribution |
| 152.550S | Outer Diameter 6.5 mm | In distribution |
| 152.567S | Outer Diameter 7.5 mm | In distribution |
| 152.148S | Outer Diameter 5.5 mm | In distribution |
| 152.487S | Length 55 mm | In distribution |
| 152.081S | Length 40 mm | In distribution |
| 152.124S | Length 34 mm | In distribution |
| 152.376S | Length 50 mm | In distribution |
| 152.114S | Length 24 mm | In distribution |
| 152.077S | Outer Diameter 5.5 mm | In distribution |
| 152.525S | Length 60 mm | In distribution |
| 152.367S | Outer Diameter 6.5 mm | In distribution |
| 152.044S | Outer Diameter 5.5 mm | In distribution |
| 152.844S | Outer Diameter 6.5 mm | In distribution |
| 152.140S | Length 20 mm | In distribution |
| 152.825S | Length 60 mm | In distribution |
| 152.160S | Length 40 mm | In distribution |
| 152.765S | Outer Diameter 7.5 mm | In distribution |
| 152.776S | Length 50 mm | In distribution |
| 152.723S | Length 50 mm | In distribution |
| 152.486S | Length 50 mm | In distribution |
| 152.086S | Outer Diameter 5.5 mm | In distribution |
| 152.476S | Length 50 mm | In distribution |
| 152.040S | Outer Diameter 5.5 mm | In distribution |
| 152.583S | Length 50 mm | In distribution |
| 152.389S | Outer Diameter 8.5 mm | In distribution |
| 152.580S | Outer Diameter 8.5 mm | In distribution |
| 152.794S | Outer Diameter 8.5 mm | In distribution |
| 152.556S | Length 65 mm | In distribution |
| 152.706S | Length 60 mm | In distribution |
| 152.701S | Length 35 mm | In distribution |
| 152.491S | Length 75 mm | In distribution |
| 152.514S | Outer Diameter 6.5 mm | In distribution |
| 152.060S | Outer Diameter 5.5 mm | In distribution |
| 152.783S | Outer Diameter 8.5 mm | In distribution |
| 152.624S | Outer Diameter 5.5 mm | In distribution |
| 152.012S | Outer Diameter 5.5 mm | In distribution |
| 152.767S | Outer Diameter 7.5 mm | In distribution |
| 152.508S | Length 70 mm | In distribution |
| 152.385S | Length 45 mm | In distribution |
| 152.574S | Outer Diameter 7.5 mm | In distribution |
| 152.732S | Length 95 mm | In distribution |
| 152.766S | Outer Diameter 7.5 mm | In distribution |
| 152.575S | Length 85 mm | In distribution |
| 152.711S | Outer Diameter 6.5 mm | In distribution |
| 152.620S | Length 30 mm | In distribution |
| 152.071S | Length 40 mm | In distribution |
| 152.822S | Outer Diameter 6.5 mm | In distribution |
| 152.477S | Outer Diameter 7.5 mm | In distribution |
| 452.150S | Length 10 mm | In distribution |
| 152.792S | Outer Diameter 8.5 mm | In distribution |
| 152.573S | Length 75 mm | In distribution |
| 152.479S | Outer Diameter 7.5 mm | In distribution |
| 152.054S | Outer Diameter 5.5 mm | In distribution |
| 152.513S | Outer Diameter 6.5 mm | In distribution |
| 152.505S | Outer Diameter 6.5 mm | In distribution |
| 152.483S | Outer Diameter 7.5 mm | In distribution |
| 152.365S | Outer Diameter 6.5 mm | In distribution |
| 152.490S | Length 70 mm | In distribution |
| 152.566S | Outer Diameter 7.5 mm | In distribution |
| 152.112S | Length 22 mm | In distribution |
| 152.823S | Length 50 mm | In distribution |
| 152.532S | Outer Diameter 7 mm | In distribution |
| 152.632S | Outer Diameter 5.5 mm | In distribution |
| 152.495S | Outer Diameter 7.5 mm | In distribution |
| 152.793S | Length 85 mm | In distribution |
| 152.588S | Outer Diameter 8.5 mm | In distribution |
| 152.521S | Length 40 mm | In distribution |
| 152.130S | Length 40 mm | In distribution |
| 152.466S | Length 50 mm | In distribution |
| 152.378S | Length 60 mm | In distribution |
| 152.511S | Outer Diameter 6.5 mm | In distribution |
| 152.026S | Length 36 mm | In distribution |
| 152.501S | Length 35 mm | In distribution |
| 152.778S | Outer Diameter 7.5 mm | In distribution |
| 152.784S | Length 40 mm | In distribution |
| 152.056S | Length 36 mm | In distribution |
| 152.812S | Outer Diameter 7.5 mm | In distribution |
| 152.058S | Outer Diameter 5.5 mm | In distribution |
| 152.702S | Length 40 mm | In distribution |
| 152.150S | Length 30 mm | In distribution |
| 152.142S | Outer Diameter 5.5 mm | In distribution |
| 152.132S | Length 42 mm | In distribution |
| 152.714S | Length 100 mm | In distribution |
| 452.020S | Length 20 mm | In distribution |
| 452.016S | Length 16 mm | In distribution |
| 452.008S | Length 8 mm | In distribution |
| 152.050S | Outer Diameter 5.5 mm | In distribution |
| 152.014S | Outer Diameter 5.5 mm | In distribution |
| 152.493S | Length 85 mm | In distribution |
Showing 250 of 278 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 311 |
| Dynesys® | Zimmer, Inc. | 139 |
| Dynesys® Top-Loading System | Zimmer, Inc. | 103 |
| Dynesys® | Zimmer Spine, Inc. | 29 |
| Zimmer® DTO® | Zimmer, Inc. | 15 |
| CD Horizon™ Astute™ Spinal System | Medtronic Sofamor Danek, Inc. | 9 |
| Dynesys Dynamic Stabilization System | Highridge Medical, LLC | 5 |
| DSS Pedicle screw set, Ø5.0 x 30mm | Paradigm Spine GmbH | 2 |
| DSS Pedicle screw set, Ø5.0 x 40mm | Paradigm Spine GmbH | 2 |
| DSS Pedicle screw set, Ø7.0 x 45mm | Paradigm Spine GmbH | 2 |
| DSS Pedicle screw set, Ø5.0 x 50mm | Paradigm Spine GmbH | 2 |
| DSS Pedicle screw set, Ø8.0 x 50mm | Paradigm Spine GmbH | 2 |
Showing 12 of 83. All products under Posterior Metal/Polymer Spinal System, Fusion
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K073439 | 2009-02-20 |
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.