FDA.reportPublic FDA data

OCTOPi Suture Anchor System

Primary DI
09353903030478
Brand
OCTOPi Suture Anchor System
Company
FIELD ORTHOPAEDICS PTY LTD
Model
OCI17
Catalog number
OCI17
Device description
OCTOPi 1.7 Instrument Kit
Published
2026-11-04
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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTWBit, DrillOrthopedic1
HTYPin, Fixation, SmoothOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09353903030478PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09353903030478093539030304789353903030478

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
09353903030331OCTOPi Suture Anchor SystemOCBR24NiOCBR24Ni2026-11-04
09353903030348OCTOPi Suture Anchor SystemOCAN242NiOCAN242Ni2026-11-04
09353903030379OCTOPi Suture Anchor SystemOCBR17NiOCBR17Ni2026-11-04
09353903030386OCTOPi Suture Anchor SystemOCAN172NiOCAN172Ni2026-11-04
09353903030393OCTOPi Suture Anchor SystemOCEX17iOCEX17i2026-11-04
09353903030416OCTOPi Suture Anchor SystemOCBR14NiOCBR14Ni2026-11-04
09353903030430OCTOPi Suture Anchor SystemOCAN142NiOCAN142Ni2026-11-04
09353903030461OCTOPi Suture Anchor SystemOCI24OCI242026-11-04
09353903030485OCTOPi Suture Anchor SystemOCI14OCI142026-11-04
09353903004240FO NX Nail SystemKWDT-12150/1KWDT-12150/12026-10-12
09353903004257FO NX Nail SystemKWDT-16150/1KWDT-16150/12026-10-12
09353903002468FO Micro Screw SystemBTSC00023BTSC000232020-05-19
09353903002475FO Micro Screw SystemBTSC00024BTSC000242020-05-19
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09353903030461OCTOPi Suture Anchor SystemFIELD ORTHOPAEDICS PTY LTDHTW2026-11-04
09353903030461OCTOPi Suture Anchor SystemFIELD ORTHOPAEDICS PTY LTDHTY2026-11-04
09353903030485OCTOPi Suture Anchor SystemFIELD ORTHOPAEDICS PTY LTDHTY2026-11-04
00841731133519REDEMPTION Beaming SystemVILEX LLCHTW2026-11-03
00841731133526REDEMPTION Beaming SystemVILEX LLCHTW2026-11-03
00841731133533REDEMPTION Beaming SystemVILEX LLCHTW2026-11-03
00841731133540REDEMPTION Beaming SystemVILEX LLCHTW2026-11-03
00841731133557REDEMPTION Beaming SystemVILEX LLCHTW2026-11-03
00841731133694REDEMPTION Beaming SystemVILEX LLCHTW2026-11-03
00889024713727G7® TM Acetabular SystemZimmer, Inc.HTW2026-11-03
00713864000313EF1Medshape, Inc.HTW2026-11-02
00713864000320EF1Medshape, Inc.HTW2026-11-02
07630894822513APTUSMedartis AGHTW2026-11-02
07630894822520APTUSMedartis AGHTW2026-11-02
07630894822605APTUSMedartis AGHTW2026-11-02
07630894822612APTUSMedartis AGHTW2026-11-02
07630894822667APTUSMedartis AGHTW2026-11-02
07630894822674APTUSMedartis AGHTW2026-11-02
03700569679279Newclip InstrumentsNEWCLIP TECHNICSHTW2026-10-30
03700569679286Newclip InstrumentsNEWCLIP TECHNICSHTW2026-10-30
03700569679293Newclip InstrumentsNEWCLIP TECHNICSHTW2026-10-30
03700569679309Newclip InstrumentsNEWCLIP TECHNICSHTW2026-10-30
00842078100363IO FiXEXTREMITY MEDICAL, LLCHTW2026-10-29
00842078100370IO FiXEXTREMITY MEDICAL, LLCHTW2026-10-29
00842078100387IO FiXEXTREMITY MEDICAL, LLCHTW2026-10-29
00842078101773XMCPEXTREMITY MEDICAL, LLCHTW2026-10-29
00842078103197IO FiX 2.0EXTREMITY MEDICAL, LLCHTW2026-10-29
00842078103227IO FiX 2.0EXTREMITY MEDICAL, LLCHTW2026-10-29
00842078109465CarpalFiXEXTREMITY MEDICAL, LLCHTW2026-10-29
00842078110379AlignXEXTREMITY MEDICAL, LLCHTW2026-10-29