Jet-X Central 71051701

GUDID 03596010613080

ANKLE SPAN- KIT STD CENTRAL BODY W TiN HALF PINS

Smith & Nephew, Inc.

External orthopaedic fixation system, single-use, sterile External orthopaedic fixation system, single-use, sterile External orthopaedic fixation system, single-use, sterile External orthopaedic fixation system, single-use, sterile External orthopaedic fixation system, single-use, sterile External orthopaedic fixation system, single-use, sterile External orthopaedic fixation system, single-use, sterile External orthopaedic fixation system, single-use, sterile External orthopaedic fixation system, single-use, sterile External orthopaedic fixation system, single-use, sterile External orthopaedic fixation system, single-use, sterile External orthopaedic fixation system, single-use, sterile External orthopaedic fixation system, single-use, sterile External orthopaedic fixation system, single-use, sterile

• Primary Device ID: 03596010613080
• NIH Device Record Key: e9086c54-f877-41f6-a99f-ed4a6d4e5167
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Jet-X Central
• Version Model Number: 71051701
• Catalog Number: 71051701
• Company DUNS: 109903521
• Company Name: Smith & Nephew, Inc.
• 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: 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)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	03596010613080 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K994143

FDA Product Code

• JDW: PIN, FIXATION, THREADED

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-01-31
• Device Publish Date: 2015-08-25

On-Brand Devices [Jet-X Central]

• 00885556011676: JET-X CENTRAL HYBRID CLAMP
• 00885556011294: JET-X EXTRA SHORT CENTRAL BODY
• 00885556011010: LARGE-FIXED STRAIGHT CLAMP
• 03596010613080: ANKLE SPAN- KIT STD CENTRAL BODY W TiN HALF PINS
• 03596010598165: JET-X CNTRL BODY TO CNTRL BODY HINGED CONNECTOR
• 03596010585356: JET-X CENTRAL TRAUMA IMPLANT CASE
• 03596010486479: JETX CENTRAL LONG COMPRESSION/DISTRACTION MODULE
• 03596010486462: STANDARD C/D MODULE
• 03596010486455: JETX CENTRAL SHORT COMPRESSION/DISTRACTION MODULE
• 03596010486448: JETX CENTRAL LONG HYRID SUPPORT STRUT
• 03596010486431: JETX CENTRAL SHORT HYBRID SUPPORT STRUT
• 03596010486424: RING ADAPTOR
• 03596010486387: LONG CENTRAL BODY
• 03596010486370: JETX CENTRAL TRAUMA STANDARD CENTRAL BODY
• 03596010486363: SHORT CENTRAL BODY
• 03596010486332: PIN TOWER
• 03596010486554: JETX CENTRAL TRAUMA INSTRUMENT CASE
• 03596010533005: JET-X CENTRAL OFFSET CLAMP
• 03596010486486: JETX TRANSLATING TRAUMA ANKLE CLAMP
• 03596010486417: T-CLAMP
• 03596010486400: STRAIGHT CLAMP
• 03596010486349: JETX CENTRAL 1.6MM X 240MM WIRE