Apelo® / Apelo® MIS
8.5mm x 35mm Cannulated Reduction Mono Screw
15manufacturers in China registered for this device type
366catalogue numbers in this listing
3510(k) clearances naming this product code
1recall
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 | Atlas Spine Inc., United States |
|---|---|
| FDA product code | NKB |
| Device type | Thoracolumbosacral Pedicle Screw System |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Establishment | Manufacturer |
| 510(k) | K072426 |
| Record published | 2014-09-24 |
| Record revised | 2024-09-11 (version 8) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Sizes | Length 1 to 500 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1100-08-0065 | Length 65 mm | In distribution |
| 1100-05-4854 | Length 48 mm | In distribution |
| 1106-01-4525 | Length 25 mm | In distribution |
| 1106-02-5535 | Length 35 mm | In distribution |
| 1100-16-0075 | Length 75 mm | In distribution |
| 1106-01-8560 | Length 60 mm | In distribution |
| 1100-16-0040 | Length 40 mm | In distribution |
| 1106-01-7540 | Length 40 mm | In distribution |
| 6900-15-0550 | In distribution | |
| 1110-01-8540 | Length 40 mm | In distribution |
| 1110-01-6545 | Length 45 mm | In distribution |
| 1106-02-5545 | Length 45 mm | In distribution |
| 1100-03-0035 | Length 35 mm | In distribution |
| 1100-05-0028 | Length 28 mm | In distribution |
| 1110-01-6560 | Length 60 mm | In distribution |
| 1106-03-4540 | Length 40 mm | In distribution |
| 1106-03-5545 | Length 45 mm | In distribution |
| 1100-03-0090 | Length 90 mm | In distribution |
| 1110-03-8535 | Length 35 mm | In distribution |
| 1100-08-0080 | Length 80 mm | In distribution |
| 1110-09-0007 | Length 7 mm | In distribution |
| 1100-10-0110 | Length 110 mm | In distribution |
| 1110-01-4525 | Length 25 mm | In distribution |
| 1100-14-0300 | Length 300 mm | In distribution |
| 1110-01-7555 | Length 55 mm | In distribution |
| 1110-04-0000 | In distribution | |
| 1106-02-7550 | Length 50 mm | In distribution |
| 1110-03-4525 | Length 25 mm | In distribution |
| 1110-09-0002 | Length 2 mm | In distribution |
| 1100-08-0040 | Length 40 mm | In distribution |
| 1106-02-8560 | Length 60 mm | In distribution |
| 1100-16-0035 | Length 35 mm | In distribution |
| 1100-16-0110 | Length 110 mm | In distribution |
| 1110-02-5530 | Length 30 mm | In distribution |
| 1100-10-0100 | Length 100 mm | In distribution |
| 1110-02-7540 | Length 40 mm | In distribution |
| 1110-03-6555 | Length 55 mm | In distribution |
| 1110-01-8545 | Length 45 mm | In distribution |
| 5010-01-0005 | In distribution | |
| 1110-02-7535 | Length 35 mm | In distribution |
| 1100-05-6066 | Length 60 mm | In distribution |
| 1110-01-5525 | Length 25 mm | In distribution |
| 1100-14-0055 | Length 55 mm | In distribution |
| 1106-02-8550 | Length 50 mm | In distribution |
| 1110-02-8530 | Length 30 mm | In distribution |
| 1110-01-4540 | Length 40 mm | In distribution |
| 6906-33-0450 | In distribution | |
| 1100-14-0400 | In distribution | |
| 1110-02-4540 | Length 40 mm | In distribution |
| 1100-10-0080 | Length 80 mm | In distribution |
| 1100-01-0040 | Length 40 mm | In distribution |
| 1110-01-8535 | Length 35 mm | In distribution |
| 1110-09-0009 | Length 9 mm | In distribution |
| 1106-03-5530 | Length 30 mm | In distribution |
| 1100-05-0020 | Length 20 mm | In distribution |
| 1106-02-6545 | Length 45 mm | In distribution |
| 1100-14-0080 | Length 80 mm | In distribution |
| 1110-02-5525 | Length 25 mm | In distribution |
| 1100-10-0085 | Length 85 mm | In distribution |
| 1106-02-8535 | Length 35 mm | In distribution |
| 1106-07-0000 | In distribution | |
| 1100-16-0060 | Length 60 mm | In distribution |
| 1110-03-4535 | Length 35 mm | In distribution |
| 1100-08-0070 | Length 70 mm | In distribution |
| 1100-03-0055 | Length 55 mm | In distribution |
| 1106-06-0000 | In distribution | |
| 1110-02-8535 | Length 35 mm | In distribution |
| 1100-03-0075 | Length 75 mm | In distribution |
| 1110-01-6550 | Length 50 mm | In distribution |
| 1106-02-8555 | Length 55 mm | In distribution |
| 1100-08-0095 | Length 95 mm | In distribution |
| 6910-20-0450 | In distribution | |
| 1110-01-6540 | Length 40 mm | In distribution |
| 1106-03-5535 | Length 35 mm | In distribution |
| 6910-26-0550 | In distribution | |
| 1100-03-0060 | Length 60 mm | In distribution |
| 1106-02-7540 | Length 40 mm | In distribution |
| 1106-01-5535 | Length 35 mm | In distribution |
| 1110-01-5535 | Length 35 mm | In distribution |
| 1100-01-0045 | Length 45 mm | In distribution |
| 1110-03-6545 | Length 45 mm | In distribution |
| 1110-03-5525 | Length 25 mm | In distribution |
| 1110-02-8540 | Length 40 mm | In distribution |
| 1106-01-6540 | Length 40 mm | In distribution |
| 1106-01-8550 | Length 50 mm | In distribution |
| 1100-10-0035 | Length 35 mm | In distribution |
| 1106-03-4545 | Length 45 mm | In distribution |
| 1100-03-0105 | Length 105 mm | In distribution |
| 1100-16-0080 | Length 80 mm | In distribution |
| 1110-03-7555 | Length 55 mm | In distribution |
| 1110-03-6535 | Length 35 mm | In distribution |
| 1106-03-7550 | Length 50 mm | In distribution |
| 1106-03-7560 | Length 60 mm | In distribution |
| 1100-08-0090 | Length 90 mm | In distribution |
| 6900-13-0550 | In distribution | |
| 1106-03-8560 | Length 60 mm | In distribution |
| 1110-02-7550 | In distribution | |
| 6910-21-0550 | In distribution | |
| 1106-01-6560 | Length 60 mm | In distribution |
| 1100-10-0055 | Length 55 mm | In distribution |
| 1110-02-4535 | Length 35 mm | In distribution |
| 1100-10-0065 | Length 65 mm | In distribution |
| 1106-03-8555 | Length 55 mm | In distribution |
| 1110-03-7540 | Length 40 mm | In distribution |
| 1106-01-5530 | Length 30 mm | In distribution |
| 1100-16-0300 | Length 300 mm | In distribution |
| 1100-08-0030 | Length 30 mm | In distribution |
| 1100-14-0030 | Length 30 mm | In distribution |
| 1110-01-6530 | Length 30 mm | In distribution |
| 1106-01-7545 | Length 45 mm | In distribution |
| 6910-22-0650 | In distribution | |
| 1106-02-5525 | Length 25 mm | In distribution |
| 1106-01-6535 | Length 35 mm | In distribution |
| 1100-10-0105 | Length 105 mm | In distribution |
| 1100-01-0095 | Length 95 mm | In distribution |
| 1110-01-7540 | Length 40 mm | In distribution |
| 1106-01-7530 | Length 30 mm | In distribution |
| 1100-14-0105 | Length 105 mm | In distribution |
| 1110-01-6535 | Length 35 mm | In distribution |
| 1100-05-0030 | Length 30 mm | In distribution |
| 1110-03-6530 | Length 30 mm | In distribution |
| 1106-01-8535 | Length 35 mm | In distribution |
| 1106-02-6560 | Length 60 mm | In distribution |
| 1100-10-0075 | In distribution | |
| 1110-02-8545 | Length 45 mm | In distribution |
| 1106-03-7530 | Length 30 mm | In distribution |
| 1106-01-7535 | Length 35 mm | In distribution |
| 1106-03-8550 | Length 50 mm | In distribution |
| 1100-16-0050 | Length 50 mm | In distribution |
| 1110-09-0004 | Length 4 mm | In distribution |
| 1100-01-0050 | Length 50 mm | In distribution |
| 1100-03-0065 | Length 65 mm | In distribution |
| 6006-07-0000 | In distribution | |
| 1106-02-6525 | Length 25 mm | In distribution |
| 1106-03-4530 | Length 30 mm | In distribution |
| 1110-09-0005 | Length 5 mm | In distribution |
| 1106-02-7545 | Length 45 mm | In distribution |
| 1100-05-0022 | Length 22 mm | In distribution |
| 1106-02-5540 | Length 40 mm | In distribution |
| 1100-08-0045 | Length 45 mm | In distribution |
| 1110-02-6540 | Length 40 mm | In distribution |
| 1110-05-0000 | In distribution | |
| 1106-02-8530 | Length 30 mm | In distribution |
| 6900-06-0450 | In distribution | |
| 1100-14-0070 | Length 70 mm | In distribution |
| 1106-01-8555 | Length 55 mm | In distribution |
| 1110-01-7535 | Length 35 mm | In distribution |
| 1100-03-0030 | Length 30 mm | In distribution |
| 1110-02-8560 | Length 60 mm | In distribution |
| 1110-01-8560 | Length 60 mm | In distribution |
| 1110-01-5530 | Length 30 mm | In distribution |
| 1110-03-5540 | Length 40 mm | In distribution |
| 1100-01-0200 | Length 200 mm | In distribution |
| 1110-03-5530 | Length 30 mm | In distribution |
| 1110-02-7545 | Length 45 mm | In distribution |
| 1100-10-0050 | In distribution | |
| 1110-03-6550 | Length 50 mm | In distribution |
| 1106-03-7540 | Length 40 mm | In distribution |
| 1106-03-7555 | Length 55 mm | In distribution |
| 1106-02-6540 | Length 40 mm | In distribution |
| 1100-05-4248 | Length 42 mm | In distribution |
| 1110-03-8555 | Length 55 mm | In distribution |
| 1110-03-8530 | Length 30 mm | In distribution |
| 1100-01-0500 | Length 500 mm | In distribution |
| 1110-09-0003 | Length 3 mm | In distribution |
| 1100-16-0065 | Length 65 mm | In distribution |
| 6006-01-0000 | In distribution | |
| 6006-06-0000 | In distribution | |
| 1110-09-0010 | Length 10 mm | In distribution |
| 1100-16-0090 | Length 90 mm | In distribution |
| 1110-03-7550 | Length 50 mm | In distribution |
| 1100-05-6672 | Length 66 mm | In distribution |
| 1106-02-6530 | Length 30 mm | In distribution |
| 1100-16-0055 | Length 55 mm | In distribution |
| 1110-01-4530 | Length 30 mm | In distribution |
| 1110-02-7530 | Length 30 mm | In distribution |
| 1100-03-0100 | In distribution | |
| 6906-33-0850 | In distribution | |
| 6006-08-0000 | In distribution | |
| 1100-14-0085 | Length 85 mm | In distribution |
| 1100-01-0090 | Length 90 mm | In distribution |
| 1106-01-7550 | Length 50 mm | In distribution |
| 1110-01-5540 | Length 40 mm | In distribution |
| 1100-03-0050 | Length 50 mm | In distribution |
| 1110-02-6550 | Length 50 mm | In distribution |
| 6910-23-0750 | In distribution | |
| 1110-02-7560 | Length 60 mm | In distribution |
| 1106-03-8535 | Length 35 mm | In distribution |
| 1106-01-5530 | In distribution | |
| 1100-08-0035 | In distribution | |
| 1100-03-0070 | Length 70 mm | In distribution |
| 1110-03-8540 | Length 40 mm | In distribution |
| 6906-33-0750 | In distribution | |
| 1106-01-5540 | Length 40 mm | In distribution |
| 6006-09-0000 | In distribution | |
| 1106-01-5545 | Length 45 mm | In distribution |
| 1100-10-0095 | Length 95 mm | In distribution |
| 1106-02-4530 | Length 30 mm | In distribution |
| 1106-03-8530 | Length 30 mm | In distribution |
| 1110-02-6525 | Length 25 mm | In distribution |
| 1100-14-0060 | Length 60 mm | In distribution |
| 1110-02-7555 | Length 55 mm | In distribution |
| 1100-01-0110 | Length 110 mm | In distribution |
| 5006-01-0000 | In distribution | |
| 1100-01-0060 | Length 60 mm | In distribution |
| 1110-01-7545 | Length 45 mm | In distribution |
| 1106-02-6555 | Length 55 mm | In distribution |
| 1106-03-6535 | Length 35 mm | In distribution |
| 1110-01-7530 | Length 30 mm | In distribution |
| 1100-14-0090 | Length 90 mm | In distribution |
| 1100-16-0070 | Length 70 mm | In distribution |
| 1100-16-0200 | Length 200 mm | In distribution |
| 1106-02-4545 | Length 45 mm | In distribution |
| 1106-02-7530 | In distribution | |
| 5006-03-0000 | In distribution | |
| 1106-02-6550 | Length 50 mm | In distribution |
| 1100-03-0080 | Length 80 mm | In distribution |
| 1110-10-0000 | In distribution | |
| 1100-14-0095 | Length 95 mm | In distribution |
| 6900-25-0550 | In distribution | |
| 1110-03-8550 | Length 50 mm | In distribution |
| 1100-05-5460 | Length 54 mm | In distribution |
| 1110-01-8550 | Length 50 mm | In distribution |
| 5006-02-0000 | In distribution | |
| 6906-33-0550 | In distribution | |
| 1106-01-6545 | Length 45 mm | In distribution |
| 1110-01-8555 | Length 55 mm | In distribution |
| 1100-03-0110 | Length 110 mm | In distribution |
| 1100-01-0085 | Length 85 mm | In distribution |
| 6900-16-0550 | In distribution | |
| 1106-02-4535 | Length 35 mm | In distribution |
| 1110-09-0001 | Length 1 mm | In distribution |
| 1100-05-0032 | Length 32 mm | In distribution |
| 1100-05-0024 | Length 24 mm | In distribution |
| 1100-01-0035 | Length 35 mm | In distribution |
| 1100-16-0045 | Length 45 mm | In distribution |
| 1100-01-0065 | Length 65 mm | In distribution |
| 6910-24-0850 | In distribution | |
| 1106-01-6525 | Length 25 mm | In distribution |
| 1100-14-01001 | Length 110 mm | In distribution |
| 1110-03-5545 | Length 45 mm | In distribution |
| 1110-02-8550 | Length 50 mm | In distribution |
| 1106-03-4535 | Length 35 mm | In distribution |
| 1106-03-5540 | Length 40 mm | In distribution |
| 1106-01-4540 | Length 40 mm | In distribution |
| 1100-16-0500 | Length 500 mm | In distribution |
| 1106-09-0000 | In distribution | |
| 1110-03-6540 | Length 40 mm | In distribution |
| 1100-01-0105 | Length 105 mm | In distribution |
| 1110-03-7530 | Length 30 mm | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
|---|---|
| K112759 | 2011-10-18 |
| K110842 | 2011-07-13 |
| K072426 | 2007-10-19 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Atlas Spine Inc. | 510(k) number | 2009-06-04 | Class II | Component design/selection | Atlas Spine, Inc. recalled their Apelo Modular Screwdriver, a component of the Apelo Pedicle Screw System Instrumentation, because of complaints received about the tip breaking. If the tip is fractured inside of the modular screw, the tip c | 4 pieces | 2014-07-16 |
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.