FDA.reportPublic FDA data

Griplasty System

Primary DI
09353903030218
Brand
Griplasty System
Company
FIELD ORTHOPAEDICS PTY LTD
Model
GPIs
Catalog number
GPIs
Device description
Instrumentation Kit
Published
2026-06-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HTWBit, Drill
HTYPin, Fixation, Smooth
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTWBit, DrillOrthopedic1
HTYPin, Fixation, SmoothOrthopedic2
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09353903030218PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09353903030218093539030302189353903030218

GMDN Terms#

Term, Definition table
TermDefinition
Cannulated surgical drill bit, single-useA metal shaft intended to be mounted into an appropriate surgical power tool (e.g., a pneumatic reamer or drilling system handpiece with appropriate torque capacity) and rotated to bore into hard/tough tissues (e.g., bone, cartilage) in order to clear a channel of the same diameter as the shaft, typically for the insertion of a prosthetic device or other orthopaedic implant. It has a hollow centre so it can be fed over a drill guiding pin, and may be flexible; devices to assist the procedure (e.g., drill guiding pin, manual driver) may be included. This is a single-use device.

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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09353903030225OCTOPi Suture Anchor SystemOCBR24NDOCBR24ND2026-07-15
09353903030317OCTOPi Suture Anchor SystemOCEX24DOCEX24D2026-07-15
09353903030324OCTOPi Suture Anchor SystemOCEX17DOCEX17D2026-07-15
09353903030201Griplasty SystemGPBOTNeGPBOTNe2026-06-24
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776404192MillenniumAvalign Technologies, Inc.LXH2026-07-24
00810135961264ToejackNVision Biomedical Technologies, Inc.HTW2026-07-24
00810135961271ToejackNVision Biomedical Technologies, Inc.LXH2026-07-24
00840314263261gSourceGSOURCE LLCLXH2026-07-24
00840314263278gSourceGSOURCE LLCLXH2026-07-24
00840314263285gSourceGSOURCE LLCLXH2026-07-24
00840314263353gSourceGSOURCE LLCLXH2026-07-24
00840314263421gSourceGSOURCE LLCLXH2026-07-24
00840314263704gSourceGSOURCE LLCLXH2026-07-24
00840314263773gSourceGSOURCE LLCLXH2026-07-24
00840314263841gSourceGSOURCE LLCLXH2026-07-24
00889024709188DISTAL GRADUATED DRILL SHORTBiomet Orthopedics, LLCHTW2026-07-24
00889024709195DRILL MEASURING SLEEVEBiomet Orthopedics, LLCLXH2026-07-24
07640221373694SCALASpineArt SALXH2026-07-24
07640221373700SCALASpineArt SALXH2026-07-24
10886982362179NASynthes GmbHLXH2026-07-24
B382SD9141071020Surgical DirectSurgical Direct, Inc.LXH2026-07-24
B382SD9141071030Surgical DirectSurgical Direct, Inc.LXH2026-07-24
B382SD9141071040Surgical DirectSurgical Direct, Inc.LXH2026-07-24
00840097534206Velora Acetabular System InstrumentationRestor3d, Inc.LXH2026-07-23
00840097534923Veritas InstrumentationRestor3d, Inc.LXH2026-07-23
00840097534930Veritas InstrumentationRestor3d, Inc.LXH2026-07-23
18059015378306Orthofix Implantable Bone ScrewsORTHOFIX SRLHTW2026-07-23
18059015378313Orthofix Implantable Bone ScrewsORTHOFIX SRLHTW2026-07-23
00190776403928MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776403935MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436025MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436032MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436049MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436056MillenniumAvalign Technologies, Inc.HTY2026-07-22