FDA.reportPublic FDA data

Tandry Q-Locking Plate System

Primary DI
04719879406788
Brand
Tandry Q-Locking Plate System
Company
MICROWARE PRECISION CO., LTD.
Model
473101K-V00
Device description
2.4mm Q-Locking H Plate, 4x2 Holes
Published
2025-12-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HRSPlate, Fixation, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRSPlate, Fixation, BoneOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K242814000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242814000Tandry Q-Locking Plate SystemMicroware Precision Co., Ltd.2024-11-14HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04719879406788PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719879406788047198794067884719879406788

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+886424636275harrisondu@microware.com.tw

Regulatory Flags#

DUNS number
658650833
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04719962166575Tandry Orthopedic Manual Surgical Instrument303027A-5002025-11-12
04719962166599Tandry Orthopedic Manual Surgical Instrument304001A-5002025-11-12
04719962169132Tandry Orthopedic Manual Surgical Instrument306011A-K002025-10-31
04719962169224Tandry Orthopedic Manual Surgical Instrument306050A-K002025-10-31
04719879398700Tandry Orthopedic Manual Surgical Instrument306045A-K002025-11-26
04719879398014Tandry Orthopedic Manual Surgical Instrument303005A-5002025-08-27
04719879398182Tandry Orthopedic Manual Surgical Instrument304007A-5002025-08-27
04719879398052Tandry Orthopedic Manual Surgical Instrument303012B-K002025-08-22
04719879398069Tandry Orthopedic Manual Surgical Instrument303013A-Z002025-08-22
04719879398113Tandry Orthopedic Manual Surgical Instrument303020A-K002025-08-22
04719879398199Tandry Orthopedic Manual Surgical Instrument304008A-K002025-08-22
04719879398229Tandry Orthopedic Manual Surgical Instrument304011A-Z002025-08-22
04719879398328Tandry Orthopedic Manual Surgical Instrument306027A-K002025-08-22
04719879398045Tandry Orthopedic Manual Surgical Instrument303012A-K002025-05-07
04719873099689BIO-RAY A-1 Anchor Screw SystemA-1H-2120082026-05-15
04719873099696BIO-RAY A-1 Anchor Screw SystemA-1H-2120102026-05-15
04719873099702BIO-RAY A-1 Anchor Screw SystemA-1H-2120122026-05-15
04719873099719BIO-RAY A-1 Anchor Screw SystemA-1H-2120142026-05-15
04719873099757BIO-RAY A-1 Anchor Screw SystemA-1HS-2220082026-05-15
04719873099764BIO-RAY A-1 Anchor Screw SystemA-1HS-2220102026-05-15

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Primary DI, Brand, Company table
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