FDA.reportPublic FDA data

FO Micro Screw System

Primary DI
09353903002475
Brand
FO Micro Screw System
Company
FIELD ORTHOPAEDICS PTY LTD
Model
BTSC00024
Catalog number
BTSC00024
Device description
FO Micro Depth Gauge (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
false

Product Codes#

Code, Name table
CodeName
HTJGauge, Depth

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTJGauge, DepthOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09353903002475PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09353903002475093539030024759353903002475

GMDN Terms#

Term, Definition table
TermDefinition
Surgical depth gauge, reusableA surgical instrument designed to measure the depth of a recess, usually to measure the depth of holes being drilled in bone so that the surgeon can determine the length of the bone screw to be used. It may take two forms: 1) a device with a moveable (sliding) centrepiece (a prong), the tip of which is inserted into the recess to read from a scale; 2) a circular disc with a central hole which is clipped to a drill bit so that the device slides up as the drill bit is advanced. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
744008914
Device count
1
DM exempt
false
Premarket exempt
true
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
09353903002468FO Micro Screw SystemBTSC00023BTSC000232020-05-19
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
09353903015413NX Nail SystemNXNC2020sNXNC2020s2023-07-16
09353903015420NX Nail SystemNXNC2022sNXNC2022s2023-07-16
09353903015437NX Nail SystemNXNC2024sNXNC2024s2023-07-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10886982345455VOLTSynthes GmbHHTJ2026-09-25
00840606191609Overwatch PCFSPINAL ELEMENTS, INC.HTJ2026-07-31
03700569674250Newclip InstrumentsNEWCLIP TECHNICSHTJ2026-07-27
03700569674274Newclip InstrumentsNEWCLIP TECHNICSHTJ2026-07-27
00842188130311Tools - ScrewsTrimed, INC.HTJ2026-07-22
06974940307243endophixSuzhou Endophix Co., Ltd.HTJ2026-06-23
08809513720045SAEHAN Hydraulic Pinch GaugeSaehan CorporationHTJ2026-05-18
08809513720359SAEHAN Mechanical Pinch GaugeSaehan CorporationHTJ2026-05-18
08800322750001AnyPlus®GS Medical Co., Ltd.HTJ2026-04-21
00810112597486TriLeap Lower Extremity Anatomic Plating SystemCROSSROADS EXTREMITY SYSTEMSHTJ2026-02-10
10850070500484Cannulated Depth Guage CURVAFIX, INC.HTJ2025-10-22
00810135963404ImpactNVision Biomedical Technologies, Inc.HTJ2025-09-24
05055662971057ORTHO SOLUTIONS SUCCESSION AFN SYSTEMORTHO SOLUTIONS HOLDINGS LIMITEDHTJ2025-08-15
08800071006862Surgical InstrumentOSTEONIC CO.,Ltd.HTJ2025-06-24
08809539690667Surgical InstrumentOSTEONIC CO.,Ltd.HTJ2025-06-24
10840199512703Depth GaugeKOROS U.S.A., INC.HTJ2024-12-31
10840199513670Multi Level Black Belt Depth GaugeKOROS U.S.A., INC.HTJ2024-12-31
00810112597936MOTOBAND InstrumentsCROSSROADS EXTREMITY SYSTEMSHTJ2024-07-31
00810112592542TriLeap Lower Extremity Anatomic Plating SystemCROSSROADS EXTREMITY SYSTEMSHTJ2024-02-23
00810112592702TriLeap Lower Extremity Anatomic Plating SystemCROSSROADS EXTREMITY SYSTEMSHTJ2024-02-23
00810112592719TriLeap Lower Extremity Anatomic Plating SystemCROSSROADS EXTREMITY SYSTEMSHTJ2024-02-23
10885862573483EPICExactech, Inc.HTJ2024-01-08
B56251300MDG000G10WishBone Plate & Screw SystemWishbone Medical, Inc.HTJ2024-01-01
07708604560472SAMPEDROINDUSTRIAS MEDICAS SAMPEDRO S A SHTJ2023-01-18
08055727374561DEPTH GAUGE 9 mmHPF SRLHTJ2022-12-09
08055727374578DEPTH GAUGE 9 mmHPF SRLHTJ2022-12-09
10603295550273INHANCEDEPUY (IRELAND)HTJ2022-12-09
10855068008607Implant Selection DeviceCURVAFIX, INC.HTJ2022-12-05
00815432028412MotoBAND CP Non Locking Drill GuideCROSSROADS EXTREMITY SYSTEMSHTJ2022-11-30
B56251300SDG000G10WishBone Plate & Screw SystemWishbone Medical, Inc.HTJ2022-07-18