Stratum

GUDID 00817701022237

STRM Locking Screw 3.5x48mm ST

NEXTREMITY SOLUTIONS, INC.

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile

• Primary Device ID: 00817701022237
• NIH Device Record Key: a6b28be5-a05d-4f42-8924-92228de585aa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Stratum
• Version Model Number: STRM-LK-3548ST
• Company DUNS: 060783407
• Company Name: NEXTREMITY SOLUTIONS, INC.
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817701022237 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182201

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: 2
• Public Version Date: 2020-05-04
• Device Publish Date: 2018-12-10

On-Brand Devices [Stratum]

• 00817701025788: STRM TORQ LIM ADAPTOR ST
• 00817701025771: STRM TORQ LIM DRIVER T10 ST
• 00817701025764: STRM Screw Driver T10 ST
• 00817701025757: STRM Drill Bit 3.5mm ST
• 00817701025740: STRM Calib Drl 2.7mm ST w SLV
• 00817701025733: STRM Calib Drl 2.5mm ST w SLV
• 00817701025726: STRM Locking Screw 2.7x20mm ST
• 00817701025719: STRM Locking Screw 2.7x18mm ST
• 00817701025702: STRM Locking Screw 2.7x16mm ST
• 00817701025696: STRM Locking Screw 2.7x14mm ST
• 00817701025689: STRM Locking Screw 2.7x12mm ST
• 00817701025672: STRM Locking Screw 2.7x10mm ST
• 00817701025665: STRM Calib Drl 2.0mm ST w SLV
• 00817701025658: Stratum Lapidus Instrument Kit
• 00817701025641: Stratum 1st MPJ Instrument Kit
• 00817701025634: Stratum Standard Instr Kit
• 00817701025627: STRM 1st MPJ Plate Large 7° Rt
• 00817701025610: STRM 1st MPJ Plate Large 7° Lt
• 00817701025603: STRM 1st MPJ Plate Std 7° Rt
• 00817701025597: STRM 1st MPJ Plate Std 7° Lt
• 00817701025580: STRM 1st MPJ Plate Small 7° Rt
• 00817701025573: STRM 1st MPJ Plate Small 7° Lt
• 00817701025566: STRM 1st MPJ Plate Large 0° Rt
• 00817701025559: STRM 1st MPJ Plate Large 0° Lt
• 00817701025542: STRM 1st MPJ Plate Std 0° Rt
• 00817701025535: STRM 1st MPJ Plate Std 0° Lt
• 00817701025528: STRM 1st MPJ Plate Small 0° Rt
• 00817701025511: STRM 1st MPJ Plate Small 0° Lt
• 00817701025504: STRM Lapidus Plate - Large Rt
• 00817701025498: STRM Lapidus Plate - Large Lt
• 00817701025481: STRM Lapidus Dorsal Medial Rt
• 00817701025474: STRM Lapidus Dorsal Medial Lt
• 00817701025467: STRM Lapidus Plate - Small Rt
• 00817701025450: STRM Lapidus Plate - Small Lt
• 00817701025443: STRM CC Plate - Large Rt
• 00817701025436: STRM CC Plate - Large Lt
• 00817701025429: STRM CC Plate - Small Rt
• 00817701025412: STRM CC Plate - Small Lt
• 00817701025405: STRM MCF Plate - Large Rt
• 00817701025399: STRM MCF Plate - Large Lt
• 00817701025382: STRM MCF Plate - Small Rt
• 00817701025375: STRM MCF Plate - Small Lt
• 00817701025368: STRM NC Plate - Large Rt
• 00817701025351: STRM NC Plate - Large Lt
• 00817701025344: STRM NC Plate - Small Rt
• 00817701025337: STRM NC Plate - Small Lt
• 00817701025320: STRM TN Plate - Large Rt
• 00817701025313: STRM TN Plate - Large Lt
• 00817701025306: STRM TN Plate - Small Rt
• 00817701025290: STRM TN Plate - Small Lt