Atoll
Catalogue number 16-40-0801, listed by Seaspine Orthopedics Corporation, United States, under Starter, Bone Screw. 4 manufacturers in China are registered for this product code.
4manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Jiangsu (2), Shanghai (1), Guangdong (1). 2 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 |
| B-ONE Medical (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Changzhou Geasure Medical Apparatus AND Instruments Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 25 |
Record
| Listed by | Seaspine Orthopedics Corporation, United States |
|---|---|
| FDA product code | HWD |
| Device type | Starter, Bone Screw |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-05-02 |
| Record revised | 2026-02-09 (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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 16-40-0801 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Power Dental USA | Power Dental U.S.A. Inc. | 64 |
| Kompressor™ Compression Screw System | Ascension Orthopedics, Inc. | 11 |
| Mariner | Seaspine Orthopedics Corporation | 8 |
| CosmoLock Pedicle Screw System | Kalitec Direct, LLC | 6 |
| Slimplicity Anterior Cervical Plate System | Precision Spine, Inc. | 5 |
| Inbone | Wright Medical Technology, Inc. | 5 |
| Universal2 Total Wrist Implant System | Smith & Nephew, Inc. | 5 |
| Universal 2™ Total Wrist Implant System | Ascension Orthopedics, Inc. | 5 |
| Countersink | Biomet Orthopedics | 5 |
| AMP-LTX | Alphatec Spine, Inc. | 4 |
| Tibiaxys® | Newdeal Sas | 3 |
| Link Instruments – Fixation instruments | Waldemar Link GmbH & Co. KG | 3 |
Showing 12 of 90. All products under Starter, Bone Screw
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.