DEVICE: Microware Bone Plates and Bone Screws (04719873051434)

Device Identifier (DI) Information

Microware Bone Plates and Bone Screws
201508F-000
In Commercial Distribution

MICROWARE PRECISION CO., LTD.
04719873051434
GS1

1
658650833 *Terms of Use
CORTEX SCREW 2.4mm x 8mm, CRUCIFORM RECESS, SELF-TAPPING, STAINLESS STEEL 316L
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
61689 Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
A non-sterile assembly of implantable devices designed for the stabilization of fractured/surgically-cut bones of the limbs (long bones), their appendages (hands, feet), pelvis, craniomaxillofacial bones, and/or for limb-joint fusion. It typically consists of a set of bone fixation plates, screws, wires, and pins made of materials that cannot be chemically degraded or absorbed via natural body processes (e.g., implant grade metal, surgical steel, titanium alloy, or carbon fibre). It may also include instruments for the attachment of the implants such as screwdrivers or drills. This device is intended to be sterilized prior to use.
Obsolete false
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
HWC Screw, Fixation, Bone
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K111008 000
No CLOSE

Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

84c49d14-4d97-46b6-8237-62feb913de71
February 19, 2024
4
August 30, 2016
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
No
Yes
No CLOSE

Customer Contact

[?]
+886424636275
harrisondu@microware.com.tw
CLOSE