SPEEDSCREW OM-9166

GUDID 00817470006384

SPEEDSCREW PLUS W/PP MGW WHITE

Smith & Nephew, Inc.

Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable

• Primary Device ID: 00817470006384
• NIH Device Record Key: 289349a1-f6bd-44a3-ab98-a50543d63d9c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SPEEDSCREW
• Version Model Number: OM-9166
• Catalog Number: OM-9166
• 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: false
• 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(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
• 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	00817470006384 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K081893

FDA Product Code

• HWC: Screw, fixation, bone

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2020-01-31
• Device Publish Date: 2015-09-21

On-Brand Devices [SPEEDSCREW]

• 00817470006414: SPEEDSCREW PLUS W/MC MGW COBRAID
• 00817470006407: SPEEDSCREW W/MC MGW WHITE
• 00817470006391: SPEEDSCREW PLUS W/PP MGW COBRAID
• 00817470006384: SPEEDSCREW PLUS W/PP MGW WHITE
• 00817470005233: 6.5MM SPEEDSCREW PLUS PP MAGNMWIRE COBRD
• 00817470005226: 6.5MM SPEEDSCREW PLUS PP MAGNMWIRE WHIT
• 00817470005219: 6.5MM SPEEDSCREW PLUS MC MW BLK COBRAID
• 00817470005202: 6.5MM SPEEDSCREW PLUS MC MAGNMWIRE COBRD
• 00817470005196: OPUS SPEEDSCREW IMPLANT
• 00817470005172: 5.5 SPEEDSCREW PLUS (BLACK COBRAID MW)
• 00817470004625: 6.5MM SPEEDSCREW PLUS MC MAGNMWIRE WHITE
• 00817470004076: SPEEDSCREW 6.5MM
• 00817470002904: SPEEDSCREW INSERTION GUIDE
• 00817470002638: SPEEDSCREW OBTURATOR
• 00817470001259: SPEEDSCREW 6.5MM PLUS PP MW BLACK COB
• 00817470001242: SPEEDSCREW 5.5MM PLUS W/PP MW BLACK COB