FDA.reportPublic FDA data

FO Micro Screw System

Primary DI
09353903000457
Brand
FO Micro Screw System
Company
FIELD ORTHOPAEDICS PTY LTD
Model
FMSK-0003
Catalog number
FMSK-0003/1
Device description
FO Micro Screw Kit Lid
Published
2019-01-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
OJHOrthopedic Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OJHOrthopedic TrayGeneral, Plastic Surgery1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K180348000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180348000Field Orthopaedics Micro Screw SystemField Orthopaedics Pty, Ltd.2018-07-17HWC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09353903000457PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09353903000457093539030004579353903000457

GMDN Terms#

Term, Definition table
TermDefinition
Instrument trayA container intended to provide a suitable platform for placing/containing many medical/surgical instruments and related items during a clinical procedure; it might in addition be used during, but not dedicated to, reprocessing/sterilization procedures. It may be in the form of a shallow vessel with a raised rim, a deeper cassette-like device, or a flat or angled surface; it might include a lid. It may be designed to fit into other devices such as supply trolleys, storage systems and sterilizers, or designed to attach to a surgical/treatment table where it may be placed over the patient. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
744008914
Device count
1
DM exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09353903030003Griplasty SystemGPBOTNGPBOTN2024-09-19
09353903001805FO Micro Screw SystemBTSC00077BTSC000772020-05-19
09353903001812FO Micro Screw SystemBTSC00078BTSC000782020-05-19
09353903001829FO Micro Screw SystemBTSC00079BTSC000792020-05-19
09353903001836FO Micro Screw SystemBTSC00080BTSC000802020-05-19
09353903001843FO Micro Screw SystemBTSC00081BTSC000812020-05-19
09353903001850FO Micro Screw SystemBTSC00082BTSC000822020-05-19
09353903001867FO Micro Screw SystemBTSC00083BTSC000832020-05-19
09353903001874FO Micro Screw SystemBTSC00084BTSC000842020-05-19
09353903001881FO Micro Screw SystemBTSC00085BTSC000852020-05-19
09353903001898FO Micro Screw SystemBTSC00086BTSC000862020-05-19
09353903001904FO Micro Screw SystemBTSC00087BTSC000872020-05-19
09353903001911FO Micro Screw SystemBTSC00088BTSC000882020-05-19
09353903002079FO Micro Screw SystemBTSC00006BTSC000062020-05-19
09353903002086FO Micro Screw SystemBTSC00007BTSC000072020-05-19
09353903002093FO Micro Screw SystemBTSC00008BTSC000082020-05-19
09353903002109FO Micro Screw SystemBTSC00009BTSC000092020-05-19
09353903002116FO Micro Screw SystemBTSC00010BTSC000102020-05-19
09353903002123FO Micro Screw SystemBTSC00011BTSC000112020-05-19
09353903002130FO Micro Screw SystemBTSC00012BTSC000122020-05-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05060267134547FORCECORDXIROS LTDOJH2026-07-06
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10198956481015CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-06
10198956484177CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-06
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10198956516571CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-06
10198956518018CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-06
10198956525597CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-06