Harmony 74016468

GUDID 00885556692011

3.2MM X 110MM NON RIMMED DRILL SPEED PIN

Smith & Nephew, Inc.

Intraoperative bone pin/screw, sterile

• Primary Device ID: 00885556692011
• NIH Device Record Key: 5534383c-12b4-4713-86c8-056da36af60f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Harmony
• Version Model Number: 74016468
• Catalog Number: 74016468
• Company DUNS: 109903521
• Company Name: Smith & Nephew, Inc.
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM

Device Identifiers

Device Issuing Agency	Device ID
GS1	00885556692011 [Primary]
GS1	20885556692015 [Package]; Package: BX [3 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113038

FDA Product Code

• HSX: PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-03-25
• Device Publish Date: 2021-03-17

On-Brand Devices [Harmony]

• 00885556758632: S+N MACRO GUIDE TIBIAL MODULE
• 00885556758625: S+N STANDARD DISTAL FEMORAL MODULE
• 00885556758618: S+N ADJUSTABLE DISTAL FEMORAL MODULE
• 00885556758649: S+N MICRO TIBIAL MODULE
• 00885556735480: EM TIBIAL ALIGNMENT TUBE MACRO
• 00885556735473: EM POSTERIOR SLOPE GUIDE
• 00885556735336: TIBIAL CUTTING GUIDE THREE DEG RIGHT
• 00885556735282: IM ROD SHORT
• 00885556735572: ANKLE CLAMP
• 00885556735459: TIBIAL STYLUS ADJUSTABLE FOOTED
• 00885556735435: TIBIAL CUTTING GUIDE THREE DEG SYMM
• 00885556735329: TIBIAL CUTTING GUIDE THREE DEG LEFT
• 00885556735442: TIBIAL CUTTING GUIDE FIVE DEG SYMM
• 00885556735428: TIBIAL CUTTING GUIDE ZERO DEG SYMM
• 00885556735350: TIBIAL CUTTING GUIDE FIVE DEG RIGHT
• 00885556735343: TIBIAL CUTTING GUIDE FIVE DEG LEFT
• 00885556788448: S+N MODULAR TIBIAL TRIAL AND PREP MODULE
• 00885556788196: S+N JOURNEY II INSERT TRIALS MODULE
• 00885556788189: S+N HALF TRAY LID
• 00885556788172: S+N HALF OUTER TRAY
• 00885556788042: S+N LEGION PRIMARY TRIALING MODULE
• 00885556787854: S+N LEGION MODULAR FEMORAL FINISHING MODULE
• 00885556787830: S+N JOURNEY II MODULAR FEMORAL FINISHING MODULE
• 00885556787809: S+N MODULAR GENERAL INSTRUMENTS MODULE
• 00885556787755: S+N FIXED FEMORAL ALIGNMENT MODULE
• 00885556787724: S+N ADJUSTABLE FEMORAL ALIGNMENT MODULE
• 00885556735565: TIBIAL CUTTING GUIDE HEAD FIVE DEG RIGHT
• 00885556735558: TIBIAL CUTTING GUIDE HEAD FIVE DEG LEFT
• 00885556735541: TIBIAL CUTTING GUIDE HEAD THREE DEG RIGHT
• 00885556735534: TIBIAL CUTTING GUIDE HEAD THREE DEG LEFT
• 00885556735503: EM TIBIAL ALIGNMENT TUBE LEGACY
• 00885556735497: EM TIBIAL ALIGNMENT TUBE MICRO
• 00885556735466: TIBIAL STYLUS 2 AND 10MM PEGGED
• 00885556735299: EM ALIGNMENT GUIDE HANDLE
• 00885556735244: SIX DEGREE VALGUS BUSHING
• 00885556735220: FOUR DEGREE VALGUS BUSHING
• 00885556735183: DISTAL CUT VALGUS GUIDE BRIDGE FIXED
• 00885556735169: DISTAL CUT VALGUS GUIDE
• 00885556758656: S+N TKA ALIGNMENT MODULE
• 00885556744536: POROUS PATELLA TRAY
• 00885556735527: EM TIBIAL ALIGNMENT GUIDE MICRO HEAD
• 00885556692011: 3.2MM X 110MM NON RIMMED DRILL SPEED PIN
• 00885556692004: 3.2MM X 75MM NON RIMMED TROCAR SPEED PIN
• 00885556691991: MIS 3.2MM X 65MM RIMMED PIN STERILE
• 00885556691984: MIS 3.2MM X 45MM RIMMED PIN STERILE
• 00885556691977: MIS 3.2MM X 30MM RIMMED PIN STERILE
• 00885556748169: RESECTION CHECK
• 00885556747995: 25MM SPACER PLATE SHIM
• 00885556747988: 21MM SPACER PLATE SHIM
• 00885556747971: 18MM SPACER PLATE SHIM