SI-RESTORE

GUDID 00850073363294

SCREWDRIVER

BIOFUSION MANAGEMENT AND MANUFACTURING, LLC

Surgical screwdriver, reusable

• Primary Device ID: 00850073363294
• NIH Device Record Key: 2d65753d-875b-404f-84ef-3ca663deef4a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SI-RESTORE
• Version Model Number: 1701-300035
• Company DUNS: 125905168
• Company Name: BIOFUSION MANAGEMENT AND MANUFACTURING, LLC
• 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: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850073363294 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182919

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[00850073363294]

Moist Heat or Steam Sterilization

[00850073363294]

Moist Heat or Steam Sterilization

[00850073363294]

Moist Heat or Steam Sterilization

[00850073363294]

Moist Heat or Steam Sterilization

[00850073363294]

Moist Heat or Steam Sterilization

[00850073363294]

Moist Heat or Steam Sterilization

[00850073363294]

Moist Heat or Steam Sterilization

[00850073363294]

Moist Heat or Steam Sterilization

[00850073363294]

Moist Heat or Steam Sterilization

[00850073363294]

Moist Heat or Steam Sterilization

[00850073363294]

Moist Heat or Steam Sterilization

[00850073363294]

Moist Heat or Steam Sterilization

[00850073363294]

Moist Heat or Steam Sterilization

[00850073363294]

Moist Heat or Steam Sterilization

[00850073363294]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-03-25
• Device Publish Date: 2025-03-17

On-Brand Devices [SI-RESTORE]

• 00850073363614: SI-RESTORE SCREW, HA BLASTED, 11.0MM x 65MM
• 00850073363607: SI-RESTORE SCREW, HA BLASTED, 11.0MM x 60MM
• 00850073363591: SI-RESTORE SCREW, HA BLASTED, 11.0MM x 55MM
• 00850073363584: SI-RESTORE SCREW, HA BLASTED, 11.0MM x 50MM
• 00850073363577: SI-RESTORE SCREW, HA BLASTED, 11.0MM x 45MM
• 00850073363560: SI-RESTORE SCREW, HA BLASTED, 11.0MM x 40MM
• 00850073363553: SI-RESTORE SCREW, HA BLASTED, 11.0MM x 35MM
• 00850073363546: SI-RESTORE SCREW, HA BLASTED, 9.5MM x 65MM
• 00850073363539: SI-RESTORE SCREW, HA BLASTED, 9.5MM x 60MM
• 00850073363522: SI-RESTORE SCREW, HA BLASTED, 9.5MM x 55MM
• 00850073363515: SI-RESTORE SCREW, HA BLASTED, 9.5MM x 50MM
• 00850073363508: SI-RESTORE SCREW, HA BLASTED, 9.5MM x 45MM
• 00850073363492: SI-RESTORE SCREW, HA BLASTED, 9.5MM x 40MM
• 00850073363485: SI-RESTORE SCREW, HA BLASTED, 9.5MM x 35MM
• 00850073363133: SI-RESTORE SCREW, 11.0MM x 65MM
• 00850073363126: SI-RESTORE SCREW, 11.0MM x 60MM
• 00850073363119: SI-RESTORE SCREW, 11.0MM x 55MM
• 00850073363102: SI-RESTORE SCREW, 11.0MM x 50MM
• 00850073363096: SI-RESTORE SCREW, 11.0MM x 45MM
• 00850073363089: SI-RESTORE SCREW, 11.0MM x 40MM
• 00850073363072: SI-RESTORE SCREW, 11.0MM x 35MM
• 00850073363065: SI-RESTORE SCREW, 9.5MM x 50MM
• 00850073363058: SI-RESTORE SCREW, 9.5MM x 50MM
• 00850073363041: SI-RESTORE SCREW, 9.5MM x 50MM
• 00850073363034: SI-RESTORE SCREW, 9.5MM x 50MM
• 00850073363027: SI-RESTORE SCREW, 9.5MM x 45MM
• 00850073363010: SI-RESTORE SCREW, 9.5MM x 40MM
• 00850073363003: SI-RESTORE SCREW, 9.5MM x 35MM
• 00850073363638: DOUBLE BARREL PIN GUIDE
• 00850073363621: T-HANDLE, 1/4" SQUARE, RATCHETING
• 00850073363430: TAP, 11.0MM
• 00850073363423: TAP, 9.5MM
• 00850073363416: DRILL, 11.0MM
• 00850073363409: DRILL, 9.5MM
• 00850073363393: SMOOTH DILATOR 3
• 00850073363386: STEINMANN PIN EXTENDER
• 00850073363379: STEINMANN PIN, 3.2MM, SHARP, EXTENDABLE
• 00850073363362: TRI-GUIDE
• 00850073363355: DILATOR HANDLE
• 00850073363348: STEINMANN PIN HOLDER
• 00850073363331: 16MM FIXED GUIDE BUMPER
• 00850073363324: 14MM FIXED GUIDE BUMPER
• 00850073363317: DILATOR 1 GAUGE
• 00850073363300: IMPLANT GRAFT FILLER POST
• 00850073363294: SCREWDRIVER
• 00850073363287: 16MM GUIDE
• 00850073363270: MALLET
• 00850073363263: SLAP HAMMER
• 00850073363256: BONE GRAFT PLUNGER
• 00850073363249: BONE GRAFT FUNNEL