Manta Ray™
Screw - Self-Drilling - Variable - 4.0x16mm
14manufacturers in China registered for this device type
152catalogue numbers in this listing
5510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (5), Shanghai (3), Zhejiang (2). 8 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| APS Materials Suzhou | Suzhou | Jiangsu | Contract manufacturer | 18 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
| Double Medical Technology Inc. | Xiamen | Fujian | Contract manufacturer | 14 |
Showing 12 of 14. All 14 manufacturers in China registered for Appliance, Fixation, Spinal Intervertebral Body
Record
| Listed by | Seaspine Orthopedics Corporation, United States |
|---|---|
| FDA product code | KWQ |
| Device type | Appliance, Fixation, Spinal Intervertebral Body |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3060 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K080690 |
| Record published | 2015-09-24 |
| Record revised | 2025-11-20 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Distribution end date | 2016-09-02 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 22-10-0234 | 34 mm | In distribution |
| 22-13-4513 | 4.5x13mm | In distribution |
| 22-24-4513 | 4.5x13mm | In distribution |
| 22-20-0120 | 20 mm | In distribution |
| 22-16-4012 | 4.0x12mm | In distribution |
| 22-20-0128 | 28 mm | In distribution |
| 22-17-4513 | 4.5x13mm | In distribution |
| 22-17-4515 | 4.5x15mm | In distribution |
| 22-21-4010 | 4.0x10mm | In distribution |
| 22-10-0246 | 46 mm | In distribution |
| 22-20-0118 | 18 mm | In distribution |
| 22-11-4016 | 4.0x16mm | In distribution |
| 22-21-4015 | 4.0x15mm | In distribution |
| 22-20-0476 | 76 mm | In distribution |
| 22-20-0472 | 72 mm | In distribution |
| 22-20-0249 | 49 mm | In distribution |
| 22-10-0357 | 57 mm | In distribution |
| 22-20-0468 | 68 mm | In distribution |
| 22-13-4515 | 4.5x15mm | In distribution |
| 22-24-4515 | 4.5x15mm | In distribution |
| 22-10-0249 | 49 mm | In distribution |
| 22-23-4013 | 4.0×13 mm | In distribution |
| 22-11-4014 | 4.0x14mm | In distribution |
| 22-14-4517 | 4.5x17mm | In distribution |
| 22-15-4016 | 4.0x16mm | In distribution |
| 22-20-0375 | 75 mm | In distribution |
| 22-17-4517 | 4.5x17mm | In distribution |
| 22-15-4010 | 4.0x10mm | In distribution |
| 22-21-4018 | 4.0x18mm | In distribution |
| 22-22-4515 | 4.5x15mm | In distribution |
| 22-23-4018 | 4.0×18 mm | In distribution |
| 22-20-0366 | 66 mm | In distribution |
| 22-15-4012 | 4.0x12mm | In distribution |
| 22-20-0231 | 31 mm | In distribution |
| 22-18-4515 | 4.5x15mm | In distribution |
| 22-20-0348 | 48 mm | In distribution |
| 22-20-0234 | 34 mm | In distribution |
| 22-20-0369 | 69 mm | In distribution |
| 22-20-0126 | 26 mm | In distribution |
| 22-20-0246 | 46 mm | In distribution |
| 22-20-0240 | 40 mm | In distribution |
| 22-12-4012 | 4.0x12mm | In distribution |
| 22-21-4013 | 4.0x13mm | In distribution |
| 22-12-4014 | 4.0x14mm | In distribution |
| 22-21-4016 | 4.0x16mm | In distribution |
| 22-23-4012 | 4.0×12 mm | In distribution |
| 22-14-4513 | 4.5x13mm | In distribution |
| 22-23-4014 | 4.0x14mm | In distribution |
| 22-20-0484 | 84 mm | In distribution |
| 22-18-4517 | 4.5x17mm | In distribution |
| 22-20-0354 | 54 mm | In distribution |
| 22-21-4012 | 4.0x12mm | In distribution |
| 22-11-4018 | 4.0x18mm | In distribution |
| 22-16-4014 | 4.0x14mm | In distribution |
| 22-20-0237 | 37 mm | In distribution |
| 22-20-0360 | 60 mm | In distribution |
| 22-20-0488 | 88 mm | In distribution |
| 22-21-4011 | 4.0x11mm | In distribution |
| 22-20-0243 | 43 mm | In distribution |
| 22-10-0126 | 26 mm | In distribution |
| 22-20-0363 | 63 mm | In distribution |
| 22-11-4010 | 4.0x10mm | In distribution |
| 22-20-0480 | 80 mm | In distribution |
| 22-11-4013 | 4.0x13mm | In distribution |
| 22-23-4010 | 4.0x10mm | In distribution |
| 22-15-4013 | 4.0x13mm | In distribution |
| 22-14-4515 | 4.5x15mm | In distribution |
| 22-24-4511 | 4.5×11 mm | In distribution |
| 22-16-4016 | 4.0x16mm | In distribution |
| 22-20-0130 | 30 mm | In distribution |
| 22-13-4517 | 4.5x 17mm | In distribution |
| 22-22-4511 | 4.5x11mm | In distribution |
| 22-20-0252 | 52 mm | In distribution |
| 22-18-4513 | 4.5x13mm | In distribution |
| 22-22-4513 | 4.5x13mm | In distribution |
| 22-20-0492 | 92 mm | In distribution |
| 22-22-4517 | 4.5x17mm | In distribution |
| 22-10-0240 | 40 mm | In distribution |
| 22-10-0124 | 24 mm | In distribution |
| 22-15-4014 | 4.0x14mm | In distribution |
| 22-21-4017 | 4.0x17mm | In distribution |
| 22-20-0372 | 72 mm | In distribution |
| 22-11-4012 | 4.0x12mm | In distribution |
| 22-11-4015 | 4.0x15mm | In distribution |
| 22-21-4014 | 4.0x14mm | In distribution |
| 22-15-4015 | 4.0x15mm | In distribution |
| 22-24-4517 | 4.5x17mm | In distribution |
| 22-23-4016 | 4.0x16mm | In distribution |
| 22-20-0132 | 32 mm | In distribution |
| 22-20-0134 | 34 mm | In distribution |
| 22-20-0122 | 22 mm | In distribution |
| 22-20-0357 | 57 mm | In distribution |
| 22-20-0351 | 51 mm | In distribution |
| 22-15-4018 | 4.0x18mm | In distribution |
| 22-22-4519 | 4.5x19mm | In distribution |
| 22-12-4016 | 4.0x16mm | Withdrawn |
| 22-23-4017 | 4.0×17 mm | Withdrawn |
| 22-10-0375 | 75 mm | Withdrawn |
| 22-12-4011 | 4.0x11mm | Withdrawn |
| 22-10-0252 | 52 mm | Withdrawn |
| 22-23-4011 | 4.0×11 mm | Withdrawn |
| 22-12-4017 | 4.0x17mm | Withdrawn |
| 22-10-0132 | 32 mm | Withdrawn |
| 22-10-0130 | 30 mm | Withdrawn |
| 22-15-4011 | 4.0x11mm | Withdrawn |
| 22-10-0134 | 34 mm | Withdrawn |
| 22-10-0372 | 72 mm | Withdrawn |
| 22-11-4017 | 4.0x17mm | Withdrawn |
| 22-12-4015 | 4.0x15mm | Withdrawn |
| 22-12-4018 | 4.0x18mm | Withdrawn |
| 22-10-0488 | 88 mm | Withdrawn |
| 22-10-0348 | 48 mm | Withdrawn |
| 22-10-0243 | 43 mm | Withdrawn |
| 22-10-0231 | 31 mm | Withdrawn |
| 22-23-4015 | 4.0×15 mm | Withdrawn |
| 22-13-4511 | 4.5x11mm | Withdrawn |
| 22-10-0237 | 37 mm | Withdrawn |
| 22-14-4511 | 4.5x11mm | Withdrawn |
| 22-10-0492 | 92 mm | Withdrawn |
| 22-10-0363 | 63 mm | Withdrawn |
| 22-10-0122 | 22 mm | Withdrawn |
| 22-12-4013 | 4.0x13mm | Withdrawn |
| 22-20-0124 | 24 mm | Withdrawn |
| 22-16-4018 | 4.0x18mm | Withdrawn |
| 22-16-4013 | 4.0x13mm | Withdrawn |
| 22-15-4017 | 4.0x17mm | Withdrawn |
| 22-18-4519 | 4.5x19mm | Withdrawn |
| 22-10-0480 | 80 mm | Withdrawn |
| 22-10-0476 | 76 mm | Withdrawn |
| 22-24-4519 | 4.5x19mm | Withdrawn |
| 22-18-4511 | 4.5x11mm | Withdrawn |
| 22-10-0354 | 54 mm | Withdrawn |
| 22-17-4511 | 4.5x11mm | Withdrawn |
| 22-12-4010 | 4.0x10mm | Withdrawn |
| 22-10-0128 | 28 mm | Withdrawn |
| 22-10-0484 | 84 mm | Withdrawn |
| 22-10-0351 | 51 mm | Withdrawn |
| 22-10-0472 | 72 mm | Withdrawn |
| 22-10-0360 | 60 mm | Withdrawn |
| 22-10-0120 | 20 mm | Withdrawn |
| 22-17-4519 | 4.5x19mm | Withdrawn |
| 22-10-0468 | 68 mm | Withdrawn |
| 22-14-4519 | 4.5x19mm | Withdrawn |
| 22-10-0118 | 18 mm | Withdrawn |
| 22-10-0369 | 69 mm | Withdrawn |
| 22-16-4011 | 4.0x11mm | Withdrawn |
| 22-16-4017 | 4.0x17mm | Withdrawn |
| 22-16-4015 | 4.0x15mm | Withdrawn |
| 22-10-0366 | 66 mm | Withdrawn |
| 22-16-4010 | 4.0x10mm | Withdrawn |
| 22-11-4011 | 4.0x11mm | Withdrawn |
| 22-13-4519 | 4.5x19mm | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| ReLine | Nuvasive, Inc. | 2,998 |
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 2,568 |
| Creo | Globus Medical, Inc. | 1,765 |
| AccelFix Spinal Fixation System | L&K Biomed Co., Ltd. | 1,755 |
| Ozark Cervical Plate System | VB Spine LLC | 1,460 |
| Sirion | Astura Medical | 1,246 |
| Apex Spine System | Spinecraft LLC | 1,187 |
| AnyPlus Spinal Fixation System | GS Medical Co., Ltd. | 986 |
| Astra Spine System | Spinecraft LLC | 970 |
| Zavation | Zavation | 966 |
| ACP | Nuvasive, Inc. | 918 |
| Polaris™ 5.5 Spinal System | Biomet Spine | 877 |
Showing 12 of 855. All products under Appliance, Fixation, Spinal Intervertebral Body
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K212139 | 2021-09-01 |
| K211903 | 2021-08-30 |
| K202064 | 2020-08-26 |
| K200885 | 2020-05-28 |
| K173521 | 2018-01-24 |
Recalls Naming This Product
2 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Integra Lifesciences Corporation | 510(k) number | 2011-01-10 | Not classified | Pending | Based upon the results of the firm’s literature review, they determined that the Package Insert (Information for Use) and information in the Surgical Technique should be revised to include additional warnings, precautions and possible adver | 244 IFU | 2011-10-27 |
| Theken Companies, LLC | 510(k) number | 2010-07-29 | Not classified | Other | The Manta Ray Cervical System was subject to corrective action by the firm after two (2) customer complaints were received alleging that screws were ‘backing out’ of the device during surgical procedures. | 1081- includes totals distributed for both plates & screws | 2012-09-21 |
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.