284107

GUDID 10886705017089

Hand Control Interface LINVATEC ApeX

DEPUY MITEK, LLC

Arthroscopic shaver system, electrically-powered

• Primary Device ID: 10886705017089
• NIH Device Record Key: c1adc1b8-93d8-4138-bba4-fe6bfd638122
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 284107
• Catalog Number: 284107
• Company DUNS: 190572854
• Company Name: DEPUY MITEK, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• 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(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	10886705017089 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K954465

FDA Product Code

• HRX: ARTHROSCOPE

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2022-07-04
• Device Publish Date: 2017-04-04

Devices Manufactured by DEPUY MITEK, LLC

• 10886705001316 - RIGIDFIX BIOCRYL: 2025-03-04 RIGIDFIX BIOCRYL TIBIAL ST CROSS PIN KIT (2) each ST Cross Pins, 3.3mm x 42mm BIOCRYL (TCP/PLA), (2) each Sleeve Assemblies, and
• 10886705000807 - PANALOK ETHIBOND: 2025-02-17 PANALOK Absorbable Anchor 3.5mm Size 2 (5 metric) green ETHIBOND braided polyester suture, 36 Inches (91cm), double-armed with C
• 10886705000920 - RIGIDFIX: 2025-02-17 RIGIDFIX TIBIAL ST CROSS PIN KIT (2) each ST Cross Pins, 3.3mm x 42mm Absorbable Poly Lactic Acid (PLA), (2) each Sleeve Assembl
• 10886705001156 - PANALOK PANACRYL: 2025-02-17 PANALOK Absorbable Anchor 3.5mm Size 2 (5 metric) PANACRYL absorbable braided suture, 36 Inches (91cm), double-armed with CP-2 n
• 10886705001323 - VERSALOK ORTHOCORD: 2025-02-17 VERSALOK PEEK ANCHOR w/ORTHOCORD PEEK Anchor (1) Violet Strand, Size 2 (5 metric) ORTHOCORD braided composite suture, 36 Inches
• 10886705001941 - PANALOK QUICKANCHOR ETHIBOND: 2025-02-17 PANALOK RC QUICKANCHOR Plus Poly (L-lactide) Absorbable Anchor Size 2 (5 metric) green ETHIBOND braided polyester suture, 36 Inc
• 10886705001965 - PANALOK QUICKANCHOR ETHIBOND: 2025-02-17 PANALOK RC QUICKANCHOR PLUS (DS) Dual Suture (DS) Poly (L-Lactide) absorbable anchor Size 2 (5 metric) Green and White ETHIBOND
• 10886705002009 - PANALOK QUICKANCHOR ORTHOCORD: 2025-02-17 PANALOK RC QUICKANCHOR Plus Poly (L-lactide) Absorbable Anchor Size 2 (5 metric) ORTHOCORD braided composite suture, 36 Inches (