FDA.reportPublic FDA data

FO Micro Screw System

Primary DI
09353903001829
Brand
FO Micro Screw System
Company
FIELD ORTHOPAEDICS PTY LTD
Model
BTSC00079
Catalog number
BTSC00079
Device description
1.5 FO Micro Screw 19mm (Cannulated)
Published
2020-05-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
HWCScrew, Fixation, Bone

Product Code Classifications#

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

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
09353903001829PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09353903001829093539030018299353903001829

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw (non-sliding)A small, threaded, non-bioabsorbable, implantable rod intended for internal orthopaedic fixation by being screwed into a limb bone, rib, the sternum and/or pelvis to hold a plate, nail, rod or prosthesis to the bone, or to provide direct interfragmentary stabilization of a fractured bone; it is not intended to be introduced through the sleeve of a femoral neck fixation plate/sleeve, not used in dentistry/orthodontics, craniofacial or spinal bones, and not dedicated to intramedullary fixation/arthrodesis. It is typically of cortical or cancellous design and has a drive (e.g., slot, cross, star, polygonal) at its proximal end for introduction with a screwdriver.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length0
Outer Diameter0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store away from moisture and direct heat.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
744008914
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09353903004240FO NX Nail SystemKWDT-12150/1KWDT-12150/12026-10-12
09353903004257FO NX Nail SystemKWDT-16150/1KWDT-16150/12026-10-12
09353903002468FO Micro Screw SystemBTSC00023BTSC000232020-05-19
09353903002475FO Micro Screw SystemBTSC00024BTSC000242020-05-19
09353903002482FO Micro Screw SystemBTSC00025BTSC000252020-05-19
09353903002499FO Micro Screw SystemBTSC00026BTSC000262020-05-19
09353903002505FO Micro Screw SystemBTSC00027BTSC000272020-05-19
09353903002529FO Micro Screw SystemBTSC00029BTSC000292020-05-19
09353903002611FO Micro Screw SystemBTSC00038BTSC000382020-05-19
09353903002512FO Micro Screw SystemBTSC00028BTSC000282020-05-19
09353903008484FO Micro Screw SystemKWST-0706/1KWST-0706/12019-12-13
09353903030201Griplasty SystemGPBOTNeGPBOTNe2026-06-24
09353903030218Griplasty SystemGPIsGPIs2026-06-24
09353903016311NX Nail SystemNXNC2045sNXNC2045s2026-04-13
09353903016328NX Nail SystemNXNC2050sNXNC2050s2026-04-13
09353903030003Griplasty SystemGPBOTNGPBOTN2024-09-19
09353903015376NX Nail SystemNXNC2012sNXNC2012s2023-07-16
09353903015383NX Nail SystemNXNC2014sNXNC2014s2023-07-16
09353903015390NX Nail SystemNXNC2016sNXNC2016s2023-07-16
09353903015406NX Nail SystemNXNC2018sNXNC2018s2023-07-16

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