Latitude-C AM™ Cervical Interbody Fusion System
Latitude-C AM is an anterior cervical interbody fusion spacer made by additive manufacturing from Puri-Ti unalloyed titanium. Each spacer is a single component with porous upper and lower…
Latitude-C AM is an anterior cervical interbody fusion spacer made by additive manufacturing from Puri-Ti unalloyed titanium. Each spacer is a single component with porous upper and lower surfaces.
A central aperture holds bone graft within the implant. Lordotic, anatomic and symmetric configurations are available, with different depths, widths, heights and angles to match the treated cervical anatomy.
Listed Item
20W X 16D X 14H X 16° Latitude-C AM™ Symmetric Modular Trial
Fusion Configuration
The implant is used with autograft and/or allogeneic cancellous or corticocancellous bone graft and supplemental fixation, such as the Cyclops anterior cervical plate system. Its cervical indication covers one or more levels from C2 to T1 in skeletally mature patients.
7manufacturers in China registered for this device type
1,529catalogue numbers in this listing
2510(k) clearances naming this product code
Who Else Makes It
Concentrated in Shanghai (2), Shandong (2), Zhejiang (2). 3 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 |
| Zhisu Health Tech Jiaxing Co., Ltd. | Tongxiang | Zhejiang | Contract manufacturer | 4 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Zhejiang Decans Medical Devices Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 10 |
| Shanghai Sanyou Medical Co., Ltd. | Shanghai | Shanghai | Manufacturer | 6 |
Record
| Listed by | Degen Medical, United States |
|---|---|
| FDA product code | ODP |
| Device type | Intervertebral Fusion Device With Bone Graft, Cervical |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K252737 |
| Record published | 2025-11-23 |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 03-16T201414L00 | In distribution | |
| 0306-201208L12 | In distribution | |
| 03-15T201511L04 | In distribution | |
| 03-15T181412L12 | In distribution | |
| 03-16T201508L08 | In distribution | |
| 03-15T201506A | In distribution | |
| 0306-201411L12 | In distribution | |
| 0306-161412L16 | In distribution | |
| 03-15T201206L04 | In distribution | |
| 0306-201511L00 | In distribution | |
| 03-16T161409L04 | In distribution | |
| 03-15T161414A | In distribution | |
| 03-16T181212L16 | In distribution | |
| 0306-201209L12 | In distribution | |
| 0306-161210L00 | In distribution | |
| 03-15T201512L16 | In distribution | |
| 03-15T161208A | In distribution | |
| 03-15T181210L16 | In distribution | |
| 0306-201407L12 | In distribution | |
| 03-16T161411L08 | In distribution | |
| 03-15T181411L08 | In distribution | |
| 03-15T181406L12 | In distribution | |
| 03-15T201212L16 | In distribution | |
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| 03-16T121206L08 | In distribution | |
| 0306-161407L12 | In distribution | |
| 0306-161211L12 | In distribution | |
| 0306-181213L00 | In distribution | |
| 0306-201514L12 | In distribution | |
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| 0306-161412L12 | In distribution | |
| 03-15T201208L04 | In distribution | |
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| 03-15T121208L12 | In distribution | |
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| 03-15T161210L12 | In distribution | |
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| 03-15T141214A | In distribution | |
| 03-16T201509L16 | In distribution | |
| 0306-161206A | In distribution | |
| 03-16T201209L12 | In distribution | |
| 0306-201414L16 | In distribution | |
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| 03-15T201414L08 | In distribution | |
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| 03-16T201509A | In distribution | |
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| 0306-141212L16 | In distribution | |
| 03-15T201508L12 | In distribution | |
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| 03-15T201210L16 | In distribution | |
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| 03-15T121209L04 | In distribution | |
| 03-15T121210L16 | In distribution | |
| 03-15T201411L00 | In distribution | |
| 0306-201412L04 | In distribution | |
| 0306-201509L08 | In distribution | |
| 0306-161208L00 | In distribution | |
| 0306-201210L16 | In distribution | |
| 03-16T161210L04 | In distribution | |
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| 03-15T161409L00 | In distribution | |
| 03-15T201214L16 | In distribution | |
| 03-15T201407L00 | In distribution | |
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Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| IdentiTi | Alphatec Spine, Inc. | 1,390 |
| Zavation | Zavation | 1,357 |
| IVA Cage Ti | Diomedical Co., Ltd. | 1,202 |
| Latitude-C Cervical Interbody Spacer System | Degen Medical | 1,185 |
| Peridot Anterior Cervical Intervertebral Body Fusion System | Gbs Commonwealth Co., Ltd. | 1,056 |
| Aleutian® Interbody Systems | VB Spine LLC | 1,017 |
| Valeo Spacer System | Sintx Technologies Inc. | 918 |
| Cascadia™ Interbody System | VB Spine LLC | 823 |
| CoRoent | Nuvasive, Inc. | 815 |
| Tyber Medical | Tyber Medical | 740 |
| Matisse Anterior Cervical Interbody Fusion Cage System | CTL Medical Corporation | 577 |
| Peridot-PT Anterior Cervical Intervertebral body fusion system | Gbs Commonwealth Co., Ltd. | 528 |
Showing 12 of 938. All products under Intervertebral Fusion Device With Bone Graft, Cervical
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K252737 | 2025-10-10 |
| K151496 | 2015-12-15 |
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.