SPEEDSCREW OM-8500

GUDID 00817470004076

SPEEDSCREW 6.5MM

Smith & Nephew, Inc.

Tendon/ligament bone anchor, non-bioabsorbable

• Primary Device ID: 00817470004076
• NIH Device Record Key: 70295ad8-d2c4-4bed-873a-b960cf43738c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SPEEDSCREW
• Version Model Number: OM-8500
• Catalog Number: OM-8500
• 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: true
• 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)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	00817470004076 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101448

FDA Product Code

• HWC: Screw, fixation, bone

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-03-21
• Device Publish Date: 2017-11-13

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