Transcend NanoTec
TRANSCEND NANOTEC PO PEEK Spacer, 11 X 10 X 25mm, 10°
5manufacturers in China registered for this device type
40catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Zhejiang (2), Guangdong (1), Jiangsu (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Zhisu Health Tech Jiaxing Co., Ltd. | Tongxiang | Zhejiang | Contract manufacturer | 4 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Zhejiang Decans Medical Devices Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 10 |
Record
| Listed by | Alphatec Spine, Inc., United States |
|---|---|
| FDA product code | OVE |
| Device type | Intervertebral Fusion Device With Integrated Fixation, Cervical |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K220782 |
| Record published | 2022-09-27 |
| Record revised | 2022-11-17 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Sizes | Width 9 to 10 mm; depth 22 to 35 mm; height 7 to 15 mm; angle 5 to 15 ° |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 144-PRO-11102510-S | Width 10 mm | In distribution |
| 144-PRO-12102515-S | Width 10 mm | In distribution |
| 144-PRO-12103010-S | Height 12 mm | In distribution |
| 140-PRO-09092210-S | Height 9 mm | In distribution |
| 144-PRO-09103515-S | Depth 35 mm | In distribution |
| 144-PRO-09103015-S | Angle 15 ° | In distribution |
| 140-PRO-10093015-S | Depth 30 mm | In distribution |
| 144-PRO-07102515-S | Depth 25 mm | In distribution |
| 144-PRO-12103515-S | Width 10 mm | In distribution |
| 144-PRO-08103015-S | Depth 30 mm | In distribution |
| 140-PRO-13093010-S | Width 9 mm | In distribution |
| 144-PRO-13103515-S | Height 13 mm | In distribution |
| 140-PRO-14092210-S | Depth 22 mm | In distribution |
| 140-PRO-07092200-S | Depth 22 mm | In distribution |
| 144-PRO-07103010-S | Height 7 mm | In distribution |
| 144-PRO-10103510-S | Depth 35 mm | In distribution |
| 144-PRO-09103010-S | Depth 30 mm | In distribution |
| 140-PRO-07092210-S | Width 9 mm | In distribution |
| 140-PRO-15092210-S | Height 15 mm | In distribution |
| 144-PRO-14102515-S | Angle 15 ° | In distribution |
| 140-PRO-13092210-S | Depth 22 mm | In distribution |
| 144-PRO-07103000-S | Height 7 mm | In distribution |
| 140-PRO-13092515-S | Height 13 mm | In distribution |
| 144-PRO-08103005-S | Width 10 mm | In distribution |
| 140-PRO-08092515-S | Angle 15 ° | In distribution |
| 144-PRO-11103005-S | Angle 5 ° | In distribution |
| 144-PRO-13103005-S | Depth 30 mm | In distribution |
| 140-PRO-11092505-S | Height 11 mm | In distribution |
| 140-PRO-08092505-S | Height 8 mm | In distribution |
| 140-PRO-07093010-S | Height 7 mm | In distribution |
| 140-PRO-13092505-S | Height 13 mm | In distribution |
| 144-PRO-13102505-S | Angle 5 ° | In distribution |
| 144-PRO-14102510-S | Depth 25 mm | In distribution |
| 144-PRO-15103005-S | Width 10 mm | In distribution |
| 144-PRO-07103505-S | Height 7 mm | In distribution |
| 140-PRO-15092205-S | Depth 22 mm | In distribution |
| 140-PRO-09093015-S | Depth 30 mm | In distribution |
| 144-PRO-11103015-S | Width 10 mm | In distribution |
| 140-PRO-10092510-S | Angle 10 ° | In distribution |
| 144-PRO-15102505-S | Depth 25 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| IdentiTi | Alphatec Spine, Inc. | 630 |
| Dolomite | Astura Medical | 607 |
| CoRoent | Nuvasive, Inc. | 580 |
| Aeon-C | Diomedical Co., Ltd. | 508 |
| Tomcat™ Cervical Spinal System | Choice Spine, LP | 468 |
| Shoreline ACS | Seaspine Orthopedics Corporation | 428 |
| Zavation | Zavation | 423 |
| Alta™ Stand-Alone Interbody Fusion System | Biomet Spine | 404 |
| Unison™-C Anterior Cervical Fixation System | Pioneer Surgical Technology, Inc. | 334 |
| Chesapeake® Stabilization System | VB Spine LLC | 272 |
| UniSpace® Stand-Alone C Cage | CG MedTech Co., Ltd. | 260 |
| Solitaire-C Cervical Spacer | Biomet Spine | 256 |
Showing 12 of 391. All products under Intervertebral Fusion Device With Integrated Fixation, Cervical
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K202812 | 2020-12-18 |
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.