Xpress Minimally Invasive Pedicle Screw System
Xpress Minimally Invasive Pedicle Screw System Instrument Set I
13manufacturers in China registered for this device type
207catalogue numbers in this listing
1recall
Who Else Makes It
Concentrated in Jiangsu (7), Shanghai (2), Shandong (2). 4 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 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| 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 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
| Double Medical Technology Inc. | Xiamen | Fujian | Contract manufacturer | 14 |
| Suzhou Kangli Orthopaedics Instrument Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
| Changzhou Yonghua Medical Instruments Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 8 |
| Jiangsu Ideal Medical Science & Technology Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 7 |
Showing 12 of 13. All 13 manufacturers in China registered for Orthosis, Spinal Pedicle Fixation
Record
| Listed by | Xtant Medical Holdings, Inc., United States |
|---|---|
| FDA product code | MNI |
| Device type | Orthosis, Spinal Pedicle Fixation |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K152132 |
| Record published | 2015-09-08 |
| Record revised | 2025-07-14 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Sizes | Outer diameter 4.75 to 8.25 mm; length 30 to 500 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| T073-0500-65-DL | Outer Diameter 6.5 mm | In distribution |
| X073-75100 | Outer Diameter 7.5 mm | In distribution |
| X073-47555 | Length 55 mm | In distribution |
| X073-6545 | Length 45 mm | In distribution |
| C073-0055 | In distribution | |
| X073-0200-S | Outer Diameter 5.5 mm | In distribution |
| X073-65100-DL | Outer Diameter 6.5 mm | In distribution |
| X073-47545 | Length 45 mm | In distribution |
| T073-1400 | In distribution | |
| X073-7560 | Outer Diameter 7.5 mm | In distribution |
| X073-0036 | In distribution | |
| X073-6575 | Length 75 mm | In distribution |
| X073-6595 | Length 95 mm | In distribution |
| C073-0090 | In distribution | |
| C073-0057 | In distribution | |
| X073-0100-CR | Length 100 mm | In distribution |
| X073-65100 | Length 100 mm | In distribution |
| C010-0084 | In distribution | |
| X073-0075-S | Outer Diameter 5.5 mm | In distribution |
| X073-0180-S | Length 180 mm | In distribution |
| C073-0075 | Outer Diameter 5.5 mm | In distribution |
| C010-0082 | In distribution | |
| X073-0085-S | Length 85 mm | In distribution |
| X073-0065-CR | Outer Diameter 5.5 mm | In distribution |
| T073-0500-65 | Outer Diameter 6.5 mm | In distribution |
| X073-6570 | Outer Diameter 6.5 mm | In distribution |
| X073-0140-CR | Length 140 mm | In distribution |
| X073-5535-DL | Length 35 mm | In distribution |
| X073-7590 | Outer Diameter 7.5 mm | In distribution |
| X073-47545-DL | Length 45 mm | In distribution |
| X073-75100-DL | Outer Diameter 7.5 mm | In distribution |
| X073-0090-S | Outer Diameter 5.5 mm | In distribution |
| X073-82595 | Length 95 mm | In distribution |
| X073-0055-S | Outer Diameter 5.5 mm | In distribution |
| X073-82570 | Length 70 mm | In distribution |
| X073-6530-DL | Length 30 mm | In distribution |
| T073-0900 | In distribution | |
| X073-6595-DL | Length 95 mm | In distribution |
| X073-0035 | In distribution | |
| X073-0500-S | Length 500 mm | In distribution |
| X073-7565 | Length 65 mm | In distribution |
| X073-7590-DL | Length 90 mm | In distribution |
| X073-0010 | In distribution | |
| X073-0150-CR | Length 150 mm | In distribution |
| X073-0085-CR | Length 85 mm | In distribution |
| X073-0100-S | Outer Diameter 5.5 mm | In distribution |
| X073-6570-DL | Length 70 mm | In distribution |
| T073-1100 | In distribution | |
| X073-0160-CR | Length 160 mm | In distribution |
| X073-825100 | Outer Diameter 8.25 mm | In distribution |
| X073-7530 | Outer Diameter 7.5 mm | In distribution |
| X073-6540 | Length 40 mm | In distribution |
| T073-1320 | In distribution | |
| X073-0080-CR | Outer Diameter 5.5 mm | In distribution |
| X073-82540-DL | Outer Diameter 8.25 mm | In distribution |
| X073-5540 | Length 40 mm | In distribution |
| X073-7565-DL | Outer Diameter 7.5 mm | In distribution |
| X073-5530 | Length 30 mm | In distribution |
| X073-7570-DL | Outer Diameter 7.5 mm | In distribution |
| X073-6550-DL | Outer Diameter 6.5 mm | In distribution |
| C010-0083 | In distribution | |
| X073-82555 | Outer Diameter 8.25 mm | In distribution |
| X073-7555 | Outer Diameter 7.5 mm | In distribution |
| X073-6540-DL | Outer Diameter 6.5 mm | In distribution |
| X073-7560-DL | Outer Diameter 7.5 mm | In distribution |
| T073-1080 | In distribution | |
| X073-82550-DL | Outer Diameter 8.25 mm | In distribution |
| X073-0070-S | Length 70 mm | In distribution |
| X073-0060-CR | Outer Diameter 5.5 mm | In distribution |
| X073-7545 | Length 45 mm | In distribution |
| X073-0050-CR | Outer Diameter 5.5 mm | In distribution |
| X073-82560 | Outer Diameter 8.25 mm | In distribution |
| C073-0078 | Outer Diameter 8.25 mm | In distribution |
| X073-0070-CR | Length 70 mm | In distribution |
| X073-0045-CR | Length 45 mm | In distribution |
| C010-0085 | In distribution | |
| X073-0300-S | Length 300 mm | In distribution |
| X073-0110-CR | Outer Diameter 5.5 mm | In distribution |
| C073-0072 | In distribution | |
| X073-7580 | Outer Diameter 7.5 mm | In distribution |
| X073-6560 | Outer Diameter 6.5 mm | In distribution |
| T073-0500-475 | Outer Diameter 4.75 mm | In distribution |
| X073-5535 | Length 35 mm | In distribution |
| X073-47535 | Outer Diameter 4.75 mm | In distribution |
| T073-0700 | In distribution | |
| X073-7595-DL | Outer Diameter 7.5 mm | In distribution |
| X073-0004 | In distribution | |
| X073-5555-DL | Outer Diameter 5.5 mm | In distribution |
| X073-82545-DL | Length 45 mm | In distribution |
| X073-6535 | Outer Diameter 6.5 mm | In distribution |
| X073-82550 | Length 50 mm | In distribution |
| C010-0075 | In distribution | |
| X073-5550-DL | Length 50 mm | In distribution |
| T073-1310 | In distribution | |
| X073-7555-DL | Length 55 mm | In distribution |
| X073-7595 | Length 95 mm | In distribution |
| C073-0095 | Outer Diameter 5.5 mm | In distribution |
| C073-0076 | Outer Diameter 6.5 mm | In distribution |
| X073-7580-DL | Outer Diameter 7.5 mm | In distribution |
| X073-0120-S | Length 120 mm | In distribution |
| X073-82585 | Outer Diameter 8.25 mm | In distribution |
| C010-0077 | In distribution | |
| X073-82565 | Length 65 mm | In distribution |
| X073-7530-DL | Length 30 mm | In distribution |
| C073-0056 | In distribution | |
| T073-0330 | In distribution | |
| X073-0014 | Outer Diameter 8.25 mm | In distribution |
| C010-0078 | In distribution | |
| X073-7545-DL | Outer Diameter 7.5 mm | In distribution |
| C073-0091 | In distribution | |
| C073-0096 | Outer Diameter 6.5 mm | In distribution |
| X073-82535-DL | Outer Diameter 8.25 mm | In distribution |
| T073-1900 | In distribution | |
| X073-82545 | Outer Diameter 8.25 mm | In distribution |
| X073-7540-DL | Outer Diameter 7.5 mm | In distribution |
| X073-0001 | In distribution | |
| X073-6590 | Outer Diameter 6.5 mm | In distribution |
| X073-47555-DL | Length 55 mm | In distribution |
| X073-82555-DL | Outer Diameter 8.25 mm | In distribution |
| C010-0087 | In distribution | |
| X073-7535 | Length 35 mm | In distribution |
| X073-6565-DL | Outer Diameter 6.5 mm | In distribution |
| X073-0075-CR | Length 75 mm | In distribution |
| X073-82590 | Outer Diameter 8.25 mm | In distribution |
| X073-6575-DL | Length 75 mm | In distribution |
| X073-6590-DL | Length 90 mm | In distribution |
| X073-82530-DL | Length 30 mm | In distribution |
| X073-0014-CS | In distribution | |
| X073-6580-DL | Outer Diameter 6.5 mm | In distribution |
| X073-82575 | Outer Diameter 8.25 mm | In distribution |
| X073-6585-DL | Length 85 mm | In distribution |
| X073-6535-DL | Outer Diameter 6.5 mm | In distribution |
| X073-0065-S | Length 65 mm | In distribution |
| X073-47540 | Length 40 mm | In distribution |
| T073-0500-75 | Outer Diameter 7.5 mm | In distribution |
| X073-0160-S | Length 160 mm | In distribution |
| T073-0500-55-DL | Outer Diameter 5.5 mm | In distribution |
| X073-6545-DL | Outer Diameter 6.5 mm | In distribution |
| X073-0028 | In distribution | |
| X073-6565 | Outer Diameter 6.5 mm | In distribution |
| X073-0007 | In distribution | |
| X073-0120-CR | Outer Diameter 5.5 mm | In distribution |
| X073-82540 | Outer Diameter 8.25 mm | In distribution |
| X073-6580 | Outer Diameter 6.5 mm | In distribution |
| C073-0060 | In distribution | |
| X073-7540 | Length 40 mm | In distribution |
| X073-82580 | Length 80 mm | In distribution |
| X073-7550-DL | Length 50 mm | In distribution |
| X073-6555 | Outer Diameter 6.5 mm | In distribution |
| X073-7570 | Outer Diameter 7.5 mm | In distribution |
| T073-1500 | In distribution | |
| C073-0094 | Outer Diameter 4.75 mm | In distribution |
| X073-0018 | In distribution | |
| X073-0090-CR | Outer Diameter 5.5 mm | In distribution |
| X073-5530-DL | Outer Diameter 5.5 mm | In distribution |
| X073-0095-S | Length 95 mm | In distribution |
| X073-6560-DL | Outer Diameter 6.5 mm | In distribution |
| X073-0050-S | Length 50 mm | In distribution |
| T073-0310 | In distribution | |
| X073-0055-CR | Outer Diameter 5.5 mm | In distribution |
| X073-5545-DL | Outer Diameter 5.5 mm | In distribution |
| X073-0040-CR | Outer Diameter 5.5 mm | In distribution |
| X073-6550 | Length 50 mm | In distribution |
| X073-5545 | Length 45 mm | In distribution |
| X073-0095-CR | Outer Diameter 5.5 mm | In distribution |
| X073-47530-DL | Outer Diameter 4.75 mm | In distribution |
| X073-82530 | Outer Diameter 8.25 mm | In distribution |
| X073-5550 | Outer Diameter 5.5 mm | In distribution |
| X073-47530 | Length 30 mm | In distribution |
| C073-0066 | In distribution | |
| X073-7585 | Outer Diameter 7.5 mm | In distribution |
| X073-7550 | Length 50 mm | In distribution |
| X073-0003 | In distribution | |
| X073-5555 | Outer Diameter 5.5 mm | In distribution |
| X073-0130-CR | Length 130 mm | In distribution |
| X073-7575 | Length 75 mm | In distribution |
| C022-0018 | In distribution | |
| X073-0010-CS | In distribution | |
| X073-0080-S | Outer Diameter 5.5 mm | In distribution |
| X073-47550-DL | Length 50 mm | In distribution |
| X073-7585-DL | Outer Diameter 7.5 mm | In distribution |
| X073-7535-DL | Length 35 mm | In distribution |
| T073-0250 | In distribution | |
| X073-0000 | In distribution | |
| X073-6585 | Length 85 mm | In distribution |
| C073-0071 | In distribution | |
| X073-6555-DL | Outer Diameter 6.5 mm | In distribution |
| X073-0140-S | Outer Diameter 5.5 mm | In distribution |
| X073-0045-S | Length 45 mm | In distribution |
| T073-2000 | In distribution | |
| X073-0038 | In distribution | |
| X073-47535-DL | Outer Diameter 4.75 mm | In distribution |
| X073-0040-S | Outer Diameter 5.5 mm | In distribution |
| X073-47540-DL | Length 40 mm | In distribution |
| X073-7575-DL | Outer Diameter 7.5 mm | In distribution |
| C073-0054 | In distribution | |
| C073-0063 | In distribution | |
| C073-0064 | In distribution | |
| X073-0060-S | Outer Diameter 5.5 mm | In distribution |
| C073-0077 | Outer Diameter 7.5 mm | In distribution |
| T073-1300 | In distribution | |
| C073-0098 | Outer Diameter 8.25 mm | In distribution |
| X073-47550 | Length 50 mm | In distribution |
| X073-82535 | Outer Diameter 8.25 mm | In distribution |
| T073-0500-55 | Outer Diameter 5.5 mm | In distribution |
| X073-6530 | Outer Diameter 6.5 mm | In distribution |
| X073-5540-DL | Length 40 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 2,342 |
| Creo | Globus Medical, Inc. | 1,784 |
| ReLine | Nuvasive, Inc. | 1,718 |
| AnyPlus Spinal Fixation System | GS Medical Co., Ltd. | 1,525 |
| Apex Spine System | Spinecraft LLC | 1,114 |
| Revere | Globus Medical, Inc. | 1,051 |
| LnK Spinal Fixation System | L&K Biomed Co., Ltd. | 974 |
| LnK Basic Spinal Fixation System | L&K Biomed Co., Ltd. | 935 |
| Arsenal | Alphatec Spine, Inc. | 932 |
| Zavation | Zavation | 864 |
| Polaris™ 5.5 Spinal System | Biomet Spine | 809 |
| Apex-DL Spine System | Spinecraft LLC | 792 |
Showing 12 of 950. All products under Orthosis, Spinal Pedicle Fixation
Recalls Naming This Product
2 recalls name this product by its own identifiers, the UDI on its label or the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Xtant Medical Holdings, Inc. | 510(k) number | 2026-02-18 | Class II | Under Investigation by firm | Units from one lot were mislabeled with an incorrect part number, identifying the device as a shorter screw length than it physically is. | 2 units | |
| Xtant Medical Holdings, Inc. | UDI-DI | 2015-03-11 | Class II | Nonconforming Material/Component | One lot of instruments have etched on the Yoke of the Pedicle Screw a laser marking size of 7.5 x 55mm instead of 5.5 x 55mm as described on the product label. | 14 units | 2015-10-21 |
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.