A8 INTEGR8® Porous Pedicle Screw System
A8 INTEGR8 is a spinal fixation system combining porous pedicle screws with polyaxial screw-head assemblies and rods. Screws anchor the construct to the spinal segments, and rods connect…
A8 INTEGR8 is a spinal fixation system combining porous pedicle screws with polyaxial screw-head assemblies and rods. Screws anchor the construct to the spinal segments, and rods connect those anchors to provide immobilization and stabilization.
The screw shafts are additively manufactured from titanium alloy. The tulips, saddles, locking rings and rods are separately machined components, distinguishing the porous screw structure from the other parts of the assembly.
Listed Item
A8 INTEGR8 Cannulated Fenestrated Porous Pedicle Screw – 1PK, Ø8.5x35mm
Rod Configurations
Rods are offered in different diameters and lengths, with straight or pre-lordosed shapes. Rod material options include titanium alloy and cobalt-chromium-molybdenum alloy; those options do not change the specified titanium alloy material of the porous screw shafts.
15manufacturers in China registered for this device type
187catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Jiangsu (6), Shanghai (3), Shandong (3). 6 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 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| 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 |
| Shanghai Reach Medical Instrument Co., Ltd. | Shanghai | Shanghai | Manufacturer | 30 |
| Changzhou Geasure Medical Apparatus AND Instruments Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 25 |
| Double Medical Technology Inc. | Xiamen | Fujian | Contract manufacturer | 14 |
Showing 12 of 15. All 15 manufacturers in China registered for Thoracolumbosacral Pedicle Screw System
Record
| Listed by | ALLUMIN8 Inc, United States |
|---|---|
| FDA product code | NKB |
| Device type | Thoracolumbosacral Pedicle Screw System |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K242827 |
| Record published | 2026-05-15 |
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 |
| Sizes | Outer diameter 5.5 to 8.5 mm; length 7 to 500 mm |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| A8-85-0035-1 | Outer Diameter 8.5 mm | In distribution | |
| RLT-55-0170 | Outer Diameter 5.5 mm | In distribution | |
| RST-55-0035 | Outer Diameter 5.5 mm | In distribution | |
| A8-75-0045-1 | Outer Diameter 7.5 mm | In distribution | |
| RST-60-0040 | Outer Diameter 6.0 mm | In distribution | |
| RST-55-0060 | Outer Diameter 5.5 mm | In distribution | |
| RST-60-0170 | Outer Diameter 6.0 mm | In distribution | |
| RST-55-0300 | Outer Diameter 5.5 mm | In distribution | |
| RLT-55-0300 | Outer Diameter 5.5 mm | In distribution | |
| A8-70-0060 | Outer Diameter 7.0 mm | 2 | In distribution |
| A8-75-0055 | Outer Diameter 7.5 mm | 2 | In distribution |
| A8-60-0055-1 | Outer Diameter 6.0 mm | In distribution | |
| RST-60-0095 | In distribution | ||
| RLT-55-0075 | Outer Diameter 5.5 mm | In distribution | |
| A8-60-0045 | Outer Diameter 6.0 mm | 2 | In distribution |
| A8-55-0030-1 | Outer Diameter 5.5 mm | In distribution | |
| A8-75-0030-1 | Outer Diameter 7.5 mm | In distribution | |
| RST-60-0085 | Outer Diameter 6.0 mm | In distribution | |
| RST-55-0045 | Outer Diameter 5.5 mm | In distribution | |
| A8-75-0055-1 | Outer Diameter 7.5 mm | In distribution | |
| A8-65-0035-1 | Outer Diameter 6.5 mm | In distribution | |
| A8-70-0045 | Outer Diameter 7.0 mm | 2 | In distribution |
| A8-70-0035-1 | Outer Diameter 7.0 mm | In distribution | |
| RLT-55-0050 | Outer Diameter 5.5 mm | In distribution | |
| RST-60-0080 | Outer Diameter 6.5 mm | In distribution | |
| RLT-55-0055 | Outer Diameter 5.5 mm | In distribution | |
| A8-85-0050 | Outer Diameter 8.5 mm | 2 | In distribution |
| A8-60-0035 | Outer Diameter 6.0 mm | 2 | In distribution |
| RST-60-0025 | Outer Diameter 6.0 mm | In distribution | |
| A8-80-0060 | Outer Diameter 8.0 mm | 2 | In distribution |
| RST-60-0400 | Outer Diameter 6.0 mm | In distribution | |
| A8-80-0055 | Outer Diameter 8.0 mm | 2 | In distribution |
| RST-60-0300 | Outer Diameter 6.0 mm | In distribution | |
| A8-80-0050-1 | Outer Diameter 8.0 mm | In distribution | |
| RLT-55-0080 | Outer Diameter 5.5 mm | In distribution | |
| A8-65-0060 | Outer Diameter 6.5 mm | 2 | In distribution |
| A8-85-0040 | Outer Diameter 8.5 mm | 2 | In distribution |
| A8-00-CAP | In distribution | ||
| A8-75-0035 | Outer Diameter 7.5 mm | 2 | In distribution |
| A8-75-0060-1 | Outer Diameter 7.5 mm | In distribution | |
| RST-55-0190 | Outer Diameter 5.5 mm | In distribution | |
| RST-55-0085 | Outer Diameter 5.5 mm | In distribution | |
| A8-60-0040-1 | Outer Diameter 6.0 mm | In distribution | |
| A8-55-0055-1 | Outer Diameter 5.5 mm | In distribution | |
| A8-75-0050-1 | Outer Diameter 7.5 mm | In distribution | |
| RST-60-0160 | Outer Diameter 6.0 mm | In distribution | |
| RST-55-0055 | Outer Diameter 5.5 mm | In distribution | |
| RST-60-0070 | Outer Diameter 6.0 mm | In distribution | |
| A8-60-0060-1 | Outer Diameter 6.0 mm | In distribution | |
| A8-70-0030-1 | Outer Diameter 7.0 mm | In distribution | |
| RST-55-0110 | Outer Diameter 5.5 mm | In distribution | |
| RLT-55-0095 | Outer Diameter 5.5 mm | In distribution | |
| A8-85-0040-1 | Outer Diameter 8.5 mm | In distribution | |
| A8-75-0060 | Outer Diameter 7.5 mm | 2 | In distribution |
| RLT-55-0030 | Outer Diameter 5.5 mm | In distribution | |
| A8-85-0030-1 | Outer Diameter 8.5 mm | In distribution | |
| RST-60-0100 | Outer Diameter 6.0 mm | In distribution | |
| RLT-55-0025 | Outer Diameter 5.5 mm | In distribution | |
| A8-80-0060-1 | Outer Diameter 8.0 mm | In distribution | |
| RST-60-0090 | Outer Diameter 6.0 mm | In distribution | |
| RST-60-0065 | Outer Diameter 6.0 mm | In distribution | |
| RST-55-0500 | Outer Diameter 5.5 mm | In distribution | |
| RLT-55-0130 | Outer Diameter 5.5 mm | In distribution | |
| RST-60-0180 | Outer Diameter 6.0 mm | In distribution | |
| RST-60-0050 | Outer Diameter 6.0 mm | In distribution | |
| A8-70-0035 | Outer Diameter 7.0 mm | 2 | In distribution |
| RLT-55-0500 | Outer Diameter 5.5 mm | In distribution | |
| RLT-55-0090 | Outer Diameter 5.5 mm | In distribution | |
| A8-70-0045-1 | Outer Diameter 7.0 mm | In distribution | |
| RLT-55-0190 | Outer Diameter 5.5 mm | In distribution | |
| A8-80-0040 | Outer Diameter 8.0 mm | 2 | In distribution |
| RST-60-0500 | Outer Diameter 6.0 mm | In distribution | |
| A8-55-0050-1 | Outer Diameter 5.5 mm | In distribution | |
| RST-60-0150 | Outer Diameter 6.0 mm | In distribution | |
| RST-60-0200 | Outer Diameter 6.0 mm | In distribution | |
| RLT-55-0110 | Outer Diameter 5.5 mm | In distribution | |
| A8-65-0055-1 | Outer Diameter 6.5 mm | In distribution | |
| A8-60-0045-1 | Outer Diameter 6.0 mm | In distribution | |
| RST-55-0180 | Outer Diameter 5.5 mm | In distribution | |
| A8-85-0045 | Outer Diameter 8.5 mm | 2 | In distribution |
| A8-60-0035-1 | Outer Diameter 6.0 mm | In distribution | |
| A8-60-0040 | Outer Diameter 6.0 mm | 2 | In distribution |
| RST-55-0025 | Outer Diameter 5.5 mm | In distribution | |
| A8-65-0045-1 | Outer Diameter 6.5 mm | In distribution | |
| A8-65-0050 | Outer Diameter 6.5 mm | 2 | In distribution |
| RST-60-0045 | Outer Diameter 6.0 mm | In distribution | |
| A8-70-0030 | Outer Diameter 7.0 mm | 2 | In distribution |
| A8-60-0030-1 | Outer Diameter 6.0 mm | In distribution | |
| A8-75-0040-1 | Outer Diameter 7.5 mm | In distribution | |
| RLT-55-0100 | Outer Diameter 5.5 mm | In distribution | |
| RLT-55-0160 | Outer Diameter 5.5 mm | In distribution | |
| RLT-55-0200 | Outer Diameter 5.5 mm | In distribution | |
| RLT-55-0120 | In distribution | ||
| A8-85-0060 | Outer Diameter 8.5 mm | 2 | In distribution |
| RLT-55-0180 | Outer Diameter 5.5 mm | In distribution | |
| A8-80-0035-1 | Outer Diameter 8.0 mm | In distribution | |
| RST-55-0040 | Outer Diameter 5.5 mm | In distribution | |
| RST-55-0120 | Outer Diameter 5.5 mm | In distribution | |
| RST-55-0080 | Outer Diameter 5.5 mm | In distribution | |
| A8-55-0040 | Outer Diameter 5.5 mm | 2 | In distribution |
| A8-65-0030 | Outer Diameter 6.5 mm | 2 | In distribution |
| A8-80-0055-1 | Outer Diameter 8.0 mm | In distribution | |
| A8-60-0030 | Outer Diameter 6.0 mm | 2 | In distribution |
| RLT-55-0085 | Outer Diameter 5.5 mm | In distribution | |
| A8-60-0055 | Outer Diameter 6.0 mm | 2 | In distribution |
| A8-80-0045 | Outer Diameter 8.0 mm | 2 | In distribution |
| RST-60-0075 | Outer Diameter 6.0 mm | In distribution | |
| A8-80-0030 | Outer Diameter 8.0 mm | 2 | In distribution |
| A8-85-0030 | Outer Diameter 8.5 mm | 2 | In distribution |
| RST-55-0050 | Outer Diameter 5.5 mm | In distribution | |
| A8-85-0035 | Outer Diameter 8.5 mm | 2 | In distribution |
| A8-55-0035 | Outer Diameter 5.5 mm | 2 | In distribution |
| A8-65-0055 | Outer Diameter 6.5 mm | 2 | In distribution |
| RLT-55-0070 | Outer Diameter 5.5 mm | In distribution | |
| RST-55-0070 | Outer Diameter 5.5 mm | In distribution | |
| A8-65-0060-1 | Outer Diameter 6.5 mm | In distribution | |
| A8-75-0050 | Outer Diameter 7.5 mm | 2 | In distribution |
| RST-55-0160 | Outer Diameter 5.5 mm | In distribution | |
| A8-80-0050 | Outer Diameter 8.0 mm | 2 | In distribution |
| A8-55-0055 | Outer Diameter 5.5 mm | 2 | In distribution |
| A8-70-0040 | Outer Diameter 7.0 mm | 2 | In distribution |
| A8-70-0050 | Outer Diameter 7.0 mm | 2 | In distribution |
| RLT-55-0150 | Outer Diameter 5.5 mm | In distribution | |
| RLT-55-0140 | Outer Diameter 5.5 mm | In distribution | |
| RST-60-0190 | Outer Diameter 6.0 mm | In distribution | |
| A8-55-0060 | Outer Diameter 5.5 mm | 2 | In distribution |
| RLT-55-0400 | Outer Diameter 5.5 mm | In distribution | |
| RST-55-0065 | Outer Diameter 5.5 mm | In distribution | |
| RLT-55-0060 | Outer Diameter 5.5 mm | In distribution | |
| A8-55-0030 | Outer Diameter 5.5 mm | 2 | In distribution |
| A8-85-0060-1 | Outer Diameter 8.5 mm | In distribution | |
| A8-65-0040 | Outer Diameter 6.5 mm | 2 | In distribution |
| A8-55-0035-1 | Outer Diameter 5.5 mm | In distribution | |
| RLT-55-0065 | Outer Diameter 5.5 mm | In distribution | |
| A8-55-0050 | Outer Diameter 5.5 mm | 2 | In distribution |
| RST-55-0200 | Outer Diameter 5.5 mm | In distribution | |
| A8-80-0035 | Outer Diameter 8.0 mm | 2 | In distribution |
| A8-75-0030 | Outer Diameter 7.5 mm | 2 | In distribution |
| A8-70-0050-1 | Outer Diameter 7.0 mm | In distribution | |
| A8-60-0050-1 | Outer Diameter 6.0 mm | In distribution | |
| RST-55-0090 | Outer Diameter 5.5 mm | In distribution | |
| RST-55-0140 | Outer Diameter 5.5 mm | In distribution | |
| A8-60-0050 | Outer Diameter 6.0 mm | 2 | In distribution |
| RST-60-0035 | Outer Diameter 6.0 mm | In distribution | |
| A8-75-0040 | Outer Diameter 7.5 mm | 2 | In distribution |
| RST-60-0110 | Outer Diameter 6.0 mm | In distribution | |
| RST-55-0100 | Outer Diameter 5.5 mm | In distribution | |
| A8-55-0045 | Outer Diameter 5.5 mm | 2 | In distribution |
| A8-85-0055-1 | Outer Diameter 8.5 mm | In distribution | |
| A8-85-0045-1 | Outer Diameter 8.5 mm | In distribution | |
| RLT-55-0035 | Outer Diameter 5.5 mm | In distribution | |
| A8-65-0035 | Outer Diameter 6.5 mm | 2 | In distribution |
| A8-27-CAP | In distribution | ||
| A8-60-0060 | Outer Diameter 6.0 mm | 2 | In distribution |
| A8-70-0055-1 | Outer Diameter 7.0 mm | In distribution | |
| A8-65-0030-1 | Outer Diameter 6.5 mm | In distribution | |
| A8-70-0040-1 | Outer Diameter 7.0 mm | In distribution | |
| RST-60-0055 | Outer Diameter 6.0 mm | In distribution | |
| A8-65-0040-1 | Outer Diameter 6.5 mm | In distribution | |
| RLT-55-0045 | Outer Diameter 5.5 mm | In distribution | |
| A8-55-0040-1 | Outer Diameter 5.5 mm | In distribution | |
| A8-70-0055 | 2 | In distribution | |
| A8-70-0060-1 | Outer Diameter 7.0 mm | In distribution | |
| RLT-55-0040 | Outer Diameter 5.5 mm | In distribution | |
| A8-55-0060-1 | Outer Diameter 5.5 mm | In distribution | |
| RST-55-0150 | Outer Diameter 5.5 mm | In distribution | |
| RST-60-0140 | Outer Diameter 6.0 mm | In distribution | |
| A8-65-0050-1 | Outer Diameter 6.5 mm | In distribution | |
| RST-60-0030 | Outer Diameter 6.0 mm | In distribution | |
| A8-85-0055 | Outer Diameter 8.5 mm | 2 | In distribution |
| RST-55-0075 | Outer Diameter 5.5 mm | In distribution | |
| RST-55-0170 | Outer Diameter 5.5 mm | In distribution | |
| RST-60-0120 | Outer Diameter 6.0 mm | In distribution | |
| A8-75-0045 | Outer Diameter 7.5 mm | 2 | In distribution |
| A8-80-0030-1 | Outer Diameter 8.0 mm | In distribution | |
| RST-55-0030 | Outer Diameter 5.5 mm | In distribution | |
| A8-80-0040-1 | Outer Diameter 8.0 mm | In distribution | |
| RST-55-0130 | Outer Diameter 5.5 mm | In distribution | |
| A8-65-0045 | Outer Diameter 6.5 mm | 2 | In distribution |
| A8-80-0045-1 | Outer Diameter 8.0 mm | In distribution | |
| A8-55-0045-1 | Outer Diameter 5.5 mm | In distribution | |
| RST-60-0060 | Outer Diameter 6.0 mm | In distribution | |
| RST-55-0400 | Outer Diameter 5.5 mm | In distribution | |
| RST-55-0095 | Outer Diameter 5.5 mm | In distribution | |
| RST-60-0130 | In distribution | ||
| A8-85-0050-1 | Outer Diameter 8.5 mm | In distribution | |
| A8-75-0035-1 | Outer Diameter 7.5 mm | In distribution |
Same Product Code
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|---|---|---|
| The Jasper Spinal Fixation System | Gbs Commonwealth Co., Ltd. | 32,491 |
| Invictus | Alphatec Spine, Inc. | 4,722 |
| Vital Spinal Fixation System | Highridge Medical, LLC | 4,422 |
| Innoverse Spinal System | CG MedTech Co., Ltd. | 4,240 |
| 4CIS® Chiron Spinal Fixation System | Alpha AI Co., Ltd. | 3,787 |
| LnK Spinal Fixation System | L&K Biomed Co., Ltd. | 3,522 |
| Hedjet System | Medyssey Co., Ltd. | 3,438 |
| Anax™ 5.5 Spinal System | CG MedTech Co., Ltd. | 3,424 |
| Mega Plus MIS Spine System | BK Meditech Co., Ltd. | 3,396 |
| ReLine | Nuvasive, Inc. | 2,882 |
| Nex-D2 | Next Orthosurgical | 2,765 |
| AnyPlus Spinal Fixation System | GS Medical Co., Ltd. | 2,386 |
Showing 12 of 1,490. All products under Thoracolumbosacral Pedicle Screw System
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K242827 | 2025-10-20 |
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.