FDA.reportPublic FDA data

Griplasty System

Primary DI
09353903030003
Brand
Griplasty System
Company
FIELD ORTHOPAEDICS PTY LTD
Model
GPBOTN
Catalog number
GPBOTN
Device description
Base of Thumb with Needles
Published
2024-09-19
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
HTWBit, Drill
HTYPin, Fixation, Smooth
LXHOrthopedic Manual Surgical Instrument
MBIFastener, Fixation, Nondegradable, Soft Tissue

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GABNeedle, Suturing, DisposableGeneral, Plastic Surgery1
HTWBit, DrillOrthopedic1
HTYPin, Fixation, SmoothOrthopedic2
LXHOrthopedic Manual Surgical InstrumentOrthopedic1
MBIFastener, Fixation, Nondegradable, Soft TissueOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09353903030003PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09353903030003093539030300039353903030003

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
09353903030201Griplasty SystemGPBOTNeGPBOTNe2026-06-24
09353903030218Griplasty SystemGPIsGPIs2026-06-24
09353903016311NX Nail SystemNXNC2045sNXNC2045s2026-04-13
09353903016328NX Nail SystemNXNC2050sNXNC2050s2026-04-13
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00724995323592V. MuellerSTERIS Deutschland GmbHLXH2026-09-25
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00840606186230ALIF Disc PrepSPINAL ELEMENTS, INC.LXH2026-09-25
00840606186261ALIFSPINAL ELEMENTS, INC.LXH2026-09-25
00840606186278ALIFSPINAL ELEMENTS, INC.LXH2026-09-25
00840606186285ALIFSPINAL ELEMENTS, INC.LXH2026-09-25
00840606187381ALIFSPINAL ELEMENTS, INC.LXH2026-09-25
00843193112699Prodisc C InstrumentCentinel Spine, LLCLXH2026-09-25
00843193112705Prodisc C InstrumentCentinel Spine, LLCLXH2026-09-25
07630040795166Surgical Manual InstrumentMedacta International SALXH2026-09-25
07630542792359Surgical Manual InstrumentMedacta International SALXH2026-09-25
10886982345431VOLTSynthes GmbHHTW2026-09-25
10886982345479VOLTSynthes GmbHHTW2026-09-25
20845854655501Argo KnotlessConmed CorporationMBI2026-09-25
20845854655501Argo KnotlessConmed CorporationLXH2026-09-25
20845854655518Argo KnotlessConmed CorporationMBI2026-09-25
20845854655518Argo KnotlessConmed CorporationLXH2026-09-25
00810130207541MSIModern Surgical Instruments LLCLXH2026-09-24
00810130207558MSIModern Surgical Instruments LLCLXH2026-09-24
00840606185929PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606185936PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606186773PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606186780PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606187237PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606187244PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606187251PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00885556854778Cadence Total Ankle SystemSmith & Nephew, Inc.LXH2026-09-24
07899258601670Orthopedic InstrumentsGM DOS REIS INDUSTRIA E COMERCIO LTDALXH2026-09-24
00190776400552MillenniumAvalign Technologies, Inc.HTW2026-07-19
00190776400576MillenniumAvalign Technologies, Inc.HTW2026-07-19