In2Bones P04 N0031

GUDID 00810021864877

CONE REAMER, 15 MM, NON-STERILE

IN2BONES USA, LLC

Orthopaedic bur, reusable

• Primary Device ID: 00810021864877
• NIH Device Record Key: 8948c59b-1a2f-45d6-81a6-59934544b2c7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: In2Bones
• Version Model Number: P04 N0031
• Catalog Number: P04 N0031
• Company DUNS: 079700711
• Company Name: IN2BONES USA, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810021864877 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163293

FDA Product Code

• LXH: Orthopedic manual surgical instrument

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00810021864877]

Moist Heat or Steam Sterilization

[00810021864877]

Moist Heat or Steam Sterilization

[00810021864877]

Moist Heat or Steam Sterilization

[00810021864877]

Moist Heat or Steam Sterilization

[00810021864877]

Moist Heat or Steam Sterilization

[00810021864877]

Moist Heat or Steam Sterilization

[00810021864877]

Moist Heat or Steam Sterilization

[00810021864877]

Moist Heat or Steam Sterilization

[00810021864877]

Moist Heat or Steam Sterilization

[00810021864877]

Moist Heat or Steam Sterilization

[00810021864877]

Moist Heat or Steam Sterilization

[00810021864877]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-12-20
• Device Publish Date: 2024-12-12

On-Brand Devices [In2Bones]

• 00810021867915: Non-beveled screwdriver T15 - AO attachment, Sterile
• 00810021867892: Beveled screwdriver T15 - AO attachment, Sterile
• 00810021867878: Non-beveled screwdriver T10 - AO attachment, Sterile
• 00810021867854: Beveled screwdriver T10 - AO attachment, Sterile
• 00810021867823: Drill for screwsDia.4.0mm, Sterile
• 00810021867809: Drill for screwsDia.3.3mm, Sterile
• 00810021867779: Countersink for screwsDia.4.0mm, Sterile
• 00810021867755: Countersink for screwsDia.3.3mm, Sterile
• 00810021867687: IBS-BDia.1.4-1.6 (2ea),2.0mm (1ea) K-Wires use w/o Mica Jig
• 00810021867670: IBS-BDia.1.4, 1.6, and2.0mm K-Wires for use w/Mica Jig, 2ea
• 00810021867663: IBS-BDia.1.6mm K-Wires, 130 and 200mm, 2ea
• 00810021867656: IBS-BDia.1.4mm K-Wires, 130 and 200mm, 2ea
• 00810021867649: Sterile Instrument,K-Wire, Ø2.0 mm L200 mm,Sterile
• 00810021867632: Sterile Instrument,K-Wire,Ø2.0mm L200mm
• 00810021867625: Single Use Sterile Instru,K-Wire, Ø2.0mm L200mm,Single Pack
• 00810021867601: Sterile Instrument,K-Wire,Ø1.6mm L200mm
• 00810021867595: Sterile Instrument,K-Wire Ø1.6 mm L200 mm,Two- Pack,Sterile
• 00810021867588: Sterile Instrument,K-Wire,Ø1.6mm L200mm
• 00810021867564: Sterile Instrument,K-Wire, Ø1.6 mm L130 mm,Sterile
• 00810021867557: Sterile Instrument,K-Wire,Ø1.6mm L130mm
• 00810021867540: Single Use Sterile Instrument,K-Wire,Single Pack,Sterile
• 00810021867526: Sterile Instrument,K-Wire,Ø1.4mm L200mm
• 00810021867519: Sterile Instrument,K-Wire,Ø1.4mm L200mm
• 00810021867502: Sterile Instrument,K-Wire,Ø1.4mm L200mm
• 00810021867489: Sterile Instrument,K-Wire,Ø1.4mm L130mm
• 00810021867472: Sterile Instrument,K-Wire, Ø1.4 mm L130 mm,Sterile
• 00810021867465: Single Use Sterile Instru,K-Wire Single Pack,Ster,Single-Use
• 00810021867083: Single Use Sterile Instrument,Ø3.5mm Solid Drill,Sterile
• 30850066074740: 5MM Constant Diameter Reamer, Single Use, Non-Sterile
• 08101755000030: K-WIRE, S. TROCAR, SMOOTH, .086 X 3.25", NON-STERILE
• 08101755000023: ADAPTOR, HUDSON COUPLING, MALE LARGE HUDSON
• 08101755000016: K-wire tube, Non-Sterile
• 00810021869780: Afx Hook Plate Trial
• 00810021869513: LAG SCREW COUNTERSINK, Ø3.0/4.0
• 00810021869506: LAG SCREW DRIVER, T15, CANNULATED, HUDSON, NON-STERILE
• 00810021869490: T25 DRIVER BIT, SOLID, NON-STERILE
• 00810021869483: DEPTH GAUGE, REUSABLE STAINLESS STEEL, 1.3 TIP, NON-STERILE
• 00810021869476: DEPTH GAUGE, MINI, REUSABLE STAINLESS STEEL, NON-STERILE
• 00810021869469: PARALLEL DRILL GUIDE FOR 2.2 MM PINS
• 00810021869452: T7 BIT- SOLID, 3.5 INCH, AO
• 00810021869445: BONE REDUCTION FORCEPS, POINTED/SERRATED, 5", NON-STERILE
• 00810021868011: ScrewsDia.6.5 soft tissues protector, Non-Sterile
• 00810021868004: ScrewsDia.6.5 drilling protector, Non-Sterile
• 00810021867991: ScrewsDia.6.5 K-wire protector, Non-Sterile
• 00810021867984: ScrewsDia.3.3 andDia.4.0 soft tissues protector, Non-Sterile
• 00810021867977: ScrewsDia.3.3 andDia.4.0 drilling protector, Non-Sterile
• 00810021867960: ScrewsDia.3.3 andDia.4.0 K-wire protector, Non-Sterile
• 00810021867953: Dia. 2.0 andDia.2.5mm L200mm K-wire measurer, Non-Sterile
• 00810021867946: Dia. 1.4 andDia.1.6 L130 and 200mm K-wire measurer, NS
• 00810021867939: Non-beveled screwdriver T25 - SMALL HUDSON attachment, NS