FDA.reportPublic FDA data

Griplasty System

Primary DI
09353903030201
Brand
Griplasty System
Company
FIELD ORTHOPAEDICS PTY LTD
Model
GPBOTNe
Catalog number
GPBOTNe
Device description
Implant On T-Handle Only
Published
2026-06-24
Public version status
Update
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
GABNeedle, Suturing, Disposable
LXHOrthopedic Manual Surgical Instrument
MBIFastener, Fixation, Nondegradable, Soft Tissue

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GABNeedle, Suturing, DisposableGeneral, Plastic Surgery1
LXHOrthopedic Manual Surgical InstrumentOrthopedic1
MBIFastener, Fixation, Nondegradable, Soft TissueOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09353903030201PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09353903030201093539030302019353903030201

GMDN Terms#

Term, Definition table
TermDefinition
Tendon/ligament bone anchor, non-bioabsorbableA non-bioabsorbable device designed to be implanted into bone for the attachment of tendons/ligaments/soft tissues either directly or via a suture attached to the device; typically used in arthroscopic or open surgical procedures. This device is available in various designs and sizes and is made of a material that cannot be chemically degraded or absorbed via natural body processes [e.g., titanium (Ti)].

Storage And Handling#

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

Regulatory Flags#

DUNS number
744008914
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
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
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
09353903015444NX Nail SystemNXNC2026sNXNC2026s2023-07-16
09353903015451NX Nail SystemNXNC2028sNXNC2028s2023-07-16
09353903015468NX Nail SystemNXNC2030sNXNC2030s2023-07-16
09353903015475NX Nail SystemNXNC2032sNXNC2032s2023-07-16
09353903015482NX Nail SystemNXNC2034sNXNC2034s2023-07-16
09353903015499NX Nail SystemNXNC2036sNXNC2036s2023-07-16
09353903015505NX Nail SystemNXNC2038sNXNC2038s2023-07-16
09353903015512NX Nail SystemNXNC2040sNXNC2040s2023-07-16
09353903001805FO Micro Screw SystemBTSC00077BTSC000772020-05-19

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Primary DI, Brand, Company table
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00840606186278ALIFSPINAL ELEMENTS, INC.LXH2026-09-25
00840606186285ALIFSPINAL ELEMENTS, INC.LXH2026-09-25
00840606187381ALIFSPINAL ELEMENTS, INC.LXH2026-09-25
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20845854655501Argo KnotlessConmed CorporationLXH2026-09-25
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20845854655518Argo KnotlessConmed CorporationLXH2026-09-25
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00810130207558MSIModern Surgical Instruments LLCLXH2026-09-24
00840606185929PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
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B7685111560Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-11-03