Microware Precision Co., Ltd.
Taichung, TW
MICROWARE PRECISION CO., LTD. appears in FDA device records in Taichung, TW. FDA records list 8 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 8 510(k) clearances for Microware Precision Co., Ltd. between 2008 and 2024. The busiest year on record is 2022, with 2. The most recent is 2024, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2008 | 1 |
| 2012 | 1 |
| 2018 | 1 |
| 2019 | 1 |
| 2022 | 2 |
| 2023 | 1 |
| 2024 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K242814 | Tandry Q-Locking Plate System | HRS | Substantially Equivalent | |
| K230690 | Tandry Locking Plate System | HRS | Substantially Equivalent | |
| K220360 | Tandry CMF Plate System | JEY | Substantially Equivalent | |
| K220359 | Tandry Compression Screw System | HWC | Substantially Equivalent | |
| K182929 | BIO-RAY A-1 Anchor Screw System | OAT | Substantially Equivalent | |
| K171904 | Tandry Locking Plate System | HRS | Substantially Equivalent | |
| K111008 | MICROWARE BONE PLATES AND BONE SCREW | HRS | Substantially Equivalent | |
| K072562 | MICROWARE BONE PLATES AND BONE SCREWS | HRS | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3007738812 | 3007738812 | MICROWARE PRECISION CO., LTD. | No. 12, Keyuan 2nd Rd., Situn District,, Taichung 407736 TW | 2026 | and 14 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- NDPAccessories, Implant, Dental, Endosseous
- KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
- LXTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite
- HTWBit, Drill
- GFFBur, Surgical, General & Plastic Surgery
- GXRCover, Burr Hole
- HBWFastener, Plate, Cranioplasty
- FZXGuide, Surgical, Instrument
- OATImplant, Endosseous, Orthodontic
- LXHOrthopedic Manual Surgical Instrument
- MNIOrthosis, Spinal Pedicle Fixation
- MNHOrthosis, Spondylolisthesis Spinal Fixation
- OSHPedicle Screw Spinal System, Adolescent Idiopathic Scoliosis
- JEYPlate, Bone
- GWOPlate, Cranioplasty, Preformed, Alterable
- GXNPlate, Cranioplasty, Preformed, Non-Alterable
- HRSPlate, Fixation, Bone
- DYJRetainer, Screw Expansion, Orthodontic
- HWCScrew, Fixation, Bone
- DZLScrew, Fixation, Intraosseous
- HWTTemplate
- NKBThoracolumbosacral Pedicle Screw System
- HTNWasher, Bolt Nut
- NDGWasher, Bolt, Nut, Non-Spinal, Metallic
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Microware Precision Co., Ltd. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
Data as of , FDA export datePage updated Source: openFDA, public domain