SPEEDLOCK OM-7535

GUDID 00817470012095

SPEEDLOCK CAPSLOCK ULTRA PROC KIT 55X8.2

Smith & Nephew, Inc.

Tendon bone anchor, non-bioabsorbable

• Primary Device ID: 00817470012095
• NIH Device Record Key: 667d4c95-35d6-4c13-84e5-5fa65a9e7b01
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SPEEDLOCK
• Version Model Number: OM-7535
• Catalog Number: OM-7535
• Company DUNS: 109903521
• Company Name: Smith & Nephew, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(978)269-4663
• Email: ROBERT.GUZMAN@SMITH-NEPHEW.COM
• Phone: +1(978)269-4663
• Email: ROBERT.GUZMAN@SMITH-NEPHEW.COM
• Phone: +1(978)269-4663
• Email: ROBERT.GUZMAN@SMITH-NEPHEW.COM

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817470012095 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130196

FDA Product Code

• MBI: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

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: 2019-01-08
• Device Publish Date: 2015-09-21

On-Brand Devices [SPEEDLOCK]

• 00817470012101: SPEEDLOCK CAPSLOCK ULTRA PROC KIT 70X8.6
• 00817470012095: SPEEDLOCK CAPSLOCK ULTRA PROC KIT 55X8.2
• 00817470010558: SPEEDLOCK
• 00817470002881: SPEEDLOCK DRILL GUIDE
• 00817470001099: SPEEDLOCK PLUS KIT W/ MAGNUMWIRE (BLACK)
• 00817470000719: LABRAFIX SPEEDLOCK PLUS IMPL
• 00817470000672: LABRAFIX SPEEDLOCK PLUS (WHITE)
• 00885556724675: SPEEDLOCK