Intercontinental
InterContinental Plate-Spacer Assembly, 6°, 20mm x 55mm, 19mm
3manufacturers in China registered for this device type
132catalogue numbers in this listing
11510(k) clearances naming this product code
Who Else Makes It
Concentrated in Shandong (2), Jiangsu (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 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
Record
| Listed by | Globus Medical, Inc., United States |
|---|---|
| FDA product code | OVD |
| Device type | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| Establishment | Manufacturer, Exporter |
| 510(k) | K103382 |
| Record published | 2015-11-06 |
| Record revised | 2025-07-14 (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 | Height 8 to 21 mm; length 30 to 65 mm; angle 6 ° |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 187.255S | Length 55 mm | In distribution |
| 387.417 | Height 17 mm | In distribution |
| 387.213 | Length 50 mm | In distribution |
| 187.009 | Height 9 mm | In distribution |
| 387.565 | Height 15 mm | In distribution |
| 387.513 | Length 65 mm | In distribution |
| 187.155S | Length 55 mm | In distribution |
| 387.063 | Height 13 mm | In distribution |
| 387.219 | Length 50 mm | In distribution |
| 387.509 | Height 9 mm | In distribution |
| 387.215 | Height 15 mm | In distribution |
| 187.008 | Height 8 mm | In distribution |
| 387.467 | Height 17 mm | In distribution |
| 387.358 | Length 55 mm | In distribution |
| 187.230S | Length 30 mm | In distribution |
| 387.159 | Angle 6 ° | In distribution |
| 387.463 | Height 13 mm | In distribution |
| 387.517 | Length 65 mm | In distribution |
| 387.015 | Length 40 mm | In distribution |
| 187.150S | Length 50 mm | In distribution |
| 187.067 | Height 17 mm | In distribution |
| 187.058 | Height 8 mm | In distribution |
| 187.160S | Length 60 mm | In distribution |
| 387.367 | Height 17 mm | In distribution |
| 187.011 | Height 11 mm | In distribution |
| 387.558 | Length 65 mm | In distribution |
| 387.461 | Angle 6 ° | In distribution |
| 387.261 | Angle 6 ° | In distribution |
| 387.515 | Height 15 mm | In distribution |
| 387.308 | Length 55 mm | In distribution |
| 187.235S | Length 35 mm | In distribution |
| 387.158 | Height 8 mm | In distribution |
| 387.471 | Height 21 mm | In distribution |
| 187.277 | Lordosis 25 Degree | In distribution |
| 187.065 | Height 15 mm | In distribution |
| 187.201 | Lordosis 20 Degree | In distribution |
| 187.059 | Lordosis 6 Degree | In distribution |
| 387.209 | Length 50 mm | In distribution |
| 387.359 | Length 55 mm | In distribution |
| 187.140S | Length 40 mm | In distribution |
| 387.421 | Height 21 mm | In distribution |
| 187.209 | Lordosis 20 Degree | In distribution |
| 387.171 | Angle 6 ° | In distribution |
| 387.169 | Length 45 mm | In distribution |
| 387.013 | Length 40 mm | In distribution |
| 387.017 | Length 40 mm | In distribution |
| 387.459 | Angle 6 ° | In distribution |
| 387.208 | Length 50 mm | In distribution |
| 387.258 | Height 8 mm | In distribution |
| 187.245S | Length 45 mm | In distribution |
| 187.061 | Lordosis 6 Degree | In distribution |
| 387.011 | Length 40 mm | In distribution |
| 387.563 | Length 65 mm | In distribution |
| 387.311 | Length 55 mm | In distribution |
| 387.221 | Length 50 mm | In distribution |
| 387.419 | Length 60 mm | In distribution |
| 387.458 | Length 60 mm | In distribution |
| 387.309 | Height 9 mm | In distribution |
| 387.411 | Length 60 mm | In distribution |
| 387.561 | Length 65 mm | In distribution |
| 387.265 | Angle 6 ° | In distribution |
| 387.108 | Length 45 mm | In distribution |
| 187.015 | Height 15 mm | In distribution |
| 187.145S | Length 45 mm | In distribution |
| 187.273 | Lordosis 25 Degree | In distribution |
| 387.115 | Length 45 mm | In distribution |
| 387.071 | Height 21 mm | In distribution |
| 387.061 | Height 11 mm | In distribution |
| 187.135S | Length 35 mm | In distribution |
| 387.009 | Height 9 mm | In distribution |
| 387.211 | Height 11 mm | In distribution |
| 387.217 | Height 17 mm | In distribution |
| 387.069 | Height 19 mm | In distribution |
| 387.521 | Height 21 mm | In distribution |
| 387.508 | Length 65 mm | In distribution |
| 387.319 | Length 55 mm | In distribution |
| 187.275 | Lordosis 25 Degree | In distribution |
| 387.065 | Height 15 mm | In distribution |
| 187.205 | Lordosis 20 Degree | In distribution |
| 387.369 | Angle 6 ° | In distribution |
| 387.519 | Height 19 mm | In distribution |
| 387.363 | Length 55 mm | In distribution |
| 387.019 | Length 40 mm | In distribution |
| 387.067 | Height 17 mm | In distribution |
| 387.167 | Angle 6 ° | In distribution |
| 387.111 | Height 11 mm | In distribution |
| 387.267 | Length 50 mm | In distribution |
| 387.058 | Angle 6 ° | In distribution |
| 387.313 | Length 55 mm | In distribution |
| 387.008 | Length 40 mm | In distribution |
| 187.240S | Length 40 mm | In distribution |
| 187.203 | Lordosis 20 Degree | In distribution |
| 387.559 | Angle 6 ° | In distribution |
| 387.321 | Height 21 mm | In distribution |
| 187.130S | Length 30 mm | In distribution |
| 387.465 | Angle 6 ° | In distribution |
| 387.259 | Angle 6 ° | In distribution |
| 387.121 | Length 45 mm | In distribution |
| 387.315 | Height 15 mm | In distribution |
| 387.165 | Length 45 mm | In distribution |
| 387.113 | Height 13 mm | In distribution |
| 387.569 | Length 65 mm | In distribution |
| 387.361 | Length 55 mm | In distribution |
| 387.109 | Height 9 mm | In distribution |
| 387.269 | Angle 6 ° | In distribution |
| 387.371 | Angle 6 ° | In distribution |
| 387.021 | Length 40 mm | In distribution |
| 387.271 | Angle 6 ° | In distribution |
| 387.163 | Length 45 mm | In distribution |
| 187.207 | Lordosis 20 Degree | In distribution |
| 387.161 | Length 45 mm | In distribution |
| 387.263 | Angle 6 ° | In distribution |
| 387.469 | Angle 6 ° | In distribution |
| 187.260S | Length 60 mm | In distribution |
| 187.013 | Height 13 mm | In distribution |
| 387.571 | Angle 6 ° | In distribution |
| 387.059 | Height 9 mm | In distribution |
| 187.281 | Height 21 mm | In distribution |
| 387.117 | Length 45 mm | In distribution |
| 387.413 | Height 13 mm | In distribution |
| 187.279 | Lordosis 25 Degree | In distribution |
| 187.250S | Length 50 mm | In distribution |
| 387.365 | Height 15 mm | In distribution |
| 187.017 | Height 17 mm | In distribution |
| 387.317 | Height 17 mm | In distribution |
| 387.408 | Height 8 mm | In distribution |
| 187.063 | Height 13 mm | In distribution |
| 387.567 | Length 65 mm | In distribution |
| 387.511 | Height 11 mm | In distribution |
| 387.119 | Length 45 mm | In distribution |
| 387.409 | Length 60 mm | In distribution |
| 387.415 | Height 15 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Sirion | Astura Medical | 1,465 |
| IdentiTi | Alphatec Spine, Inc. | 1,372 |
| EL Capitan | Astura Medical | 1,205 |
| Zavation | Zavation | 1,157 |
| Brigade | Nuvasive, Inc. | 1,005 |
| Solar™ Interbody Fusion System | Degen Medical | 899 |
| Zavation F3D Corpectomy | Zavation | 730 |
| ROI-A | Ldr Spine USA | 552 |
| Avenue L | Ldr Spine USA | 524 |
| Transcend Nanotec | Alphatec Spine, Inc. | 485 |
| Endoskeleton® TL Hyperlordotic nanoLOCK® Surface Technology | Titan Spine, LLC | 462 |
| Base | Nuvasive, Inc. | 462 |
Showing 12 of 241. All products under Intervertebral Fusion Device With Integrated Fixation, Lumbar
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K253401 | 2026-04-29 |
| K201087 | 2020-07-31 |
| K170157 | 2017-09-25 |
| K161379 | 2016-09-29 |
| K160597 | 2016-08-29 |
| K161223 | 2016-07-15 |
| K142498 | 2015-02-26 |
| K132559 | 2013-12-30 |
| K120101 | 2012-03-27 |
| K103382 | 2011-05-20 |
| K082252 | 2008-11-05 |
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.