FDA.reportPublic FDA data

OCTOPi Suture Anchor System

Primary DI
09353903030317
Brand
OCTOPi Suture Anchor System
Company
FIELD ORTHOPAEDICS PTY LTD
Model
OCEX24D
Catalog number
OCEX24D
Device description
OCTOExtend Push 2.4 with Cannulated Drill
Published
2026-07-15
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
HTWBit, Drill
HTYPin, Fixation, Smooth
LXHOrthopedic Manual Surgical Instrument
MBIFastener, Fixation, Nondegradable, Soft Tissue

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTWBit, DrillOrthopedic1
HTYPin, Fixation, SmoothOrthopedic2
LXHOrthopedic Manual Surgical InstrumentOrthopedic1
MBIFastener, Fixation, Nondegradable, Soft TissueOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09353903030317PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09353903030317093539030303179353903030317

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
09353903030225OCTOPi Suture Anchor SystemOCBR24NDOCBR24ND2026-07-15
09353903030324OCTOPi Suture Anchor SystemOCEX17DOCEX17D2026-07-15
09353903030201Griplasty SystemGPBOTNeGPBOTNe2026-06-24
09353903030218Griplasty SystemGPIsGPIs2026-06-24
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

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Primary DI, Brand, Company table
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00841523183081Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-08-07
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00841523185047Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-08-07
00841523185054Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-08-07
00841523185061Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-08-07
00841523185078Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-08-07
00841523185092Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-08-07
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B382SD484620Surgical DirectSurgical Direct, Inc.LXH2026-08-07
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B382SD493760Surgical DirectSurgical Direct, Inc.LXH2026-08-03
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