General Instruments
AWL TAP Handle, TWO Piece Stylet Wire, Diamond
13manufacturers in China registered for this device type
36catalogue numbers in this listing
1recall
Who Else Makes It
Concentrated in Shanghai (3), Shandong (3), Jiangsu (3). 4 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 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Xinhua Healthcare Industry Co., Limited | Zibo | Shandong | Contract manufacturer | 30 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Beijing Fule Science & Technology Development Co., Ltd. | Beijing | Beijing | Manufacturer | 31 |
| Shanghai Reach Medical Instrument Co., Ltd. | Shanghai | Shanghai | Manufacturer | 30 |
| Changzhou Geasure Medical Apparatus AND Instruments Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 25 |
| Bothwin (Beijing) Medical Technology Co., Ltd. | Beijng | Beijing | Manufacturer | 25 |
Showing 12 of 13. All 13 manufacturers in China registered for Awl
Record
| Listed by | Alphatec Spine, Inc., United States |
|---|---|
| FDA product code | HWJ |
| Device type | Awl |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2024-11-18 |
| Record revised | 2024-06-03 (version 2) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CI-11597-300-20 | In distribution | |
| CI-11359 | In distribution | |
| CI-11508-01 | In distribution | |
| CI-11620 | In distribution | |
| CI-11530-30 | In distribution | |
| CI-11315-100 | In distribution | |
| CI-11415-01 | In distribution | |
| CI-11597-300-10 | In distribution | |
| CI-11415-02-02 | In distribution | |
| CI-11508-02 | In distribution | |
| CI-11537-75 | In distribution | |
| CI-11537-55 | In distribution | |
| CI-11537-45 | In distribution | |
| CI-11415-02-01 | In distribution | |
| CI-11597-500 | In distribution | |
| CI-11615 | In distribution | |
| CI-11315-055-10 | In distribution | |
| CI-11461 | In distribution | |
| CI-10176 | In distribution | |
| CI-11597-045-10 | In distribution | |
| CI-11315-200-10 | In distribution | |
| CI-11315-045-10 | In distribution | |
| CI-11582 | In distribution | |
| CI-10032 | In distribution | |
| CI-11698 | In distribution | |
| CI-10310 | In distribution | |
| CI-11700-055 | In distribution | |
| CI-11406-30 | In distribution | |
| CI-11707 | In distribution | |
| CI-11597-045-20 | In distribution | |
| CI-11597-100 | In distribution | |
| CI-11530-10 | In distribution | |
| CI-11762 | In distribution | |
| CI-11530-20 | In distribution | |
| CI-10102 | In distribution | |
| CI-11597-200 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medtronic Reusable Instruments | Medtronic Sofamor Danek, Inc. | 91 |
| HNM Medical | HNM Stainless, LLC. | 42 |
| Awl | Synthes Gmbh | 41 |
| Alta Acdf System | Highridge Medical, LLC | 34 |
| Awl | Depuy Spine, Inc. | 30 |
| Brickyard Stand-Alone Alif | Altus Spine | 28 |
| Generic Surgical Instruments | CTL Medical Corporation | 26 |
| IdentiTi | Alphatec Spine, Inc. | 23 |
| Indy Standalone | Altus Spine | 23 |
| Invictus | Alphatec Spine, Inc. | 22 |
| Tecomet | Tecomet, Inc. | 21 |
| Sklar® | Sklar Corporation | 21 |
Showing 12 of 480. All products under Awl
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2023-07-07 | Class II | Nonconforming Material/Component | Awl instrument adjustable drill button assembly assembled in the incorrect orientation, preventing locking feature from engaging with shaft at the desired set point; instruments lack ability to control awl depth by means of adjustable shaft | 29 |
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.