STABOLT

GUDID 03613720192923

3 HOLES LUMBOSACRAL PLATE Size 4 at 115°

MEDICREA INTERNATIONAL

Spinal fixation plate, non-bioabsorbable

• Primary Device ID: 03613720192923
• NIH Device Record Key: 4a72b09f-496e-499d-b132-b47fc8a63e10
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STABOLT
• Version Model Number: B14031615
• Company DUNS: 383228632
• Company Name: MEDICREA INTERNATIONAL
• 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: false
• 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	03613720192923 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121323

FDA Product Code

• KWQ: Appliance, Fixation, Spinal Intervertebral Body

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: 2022-05-23
• Device Publish Date: 2015-10-23

On-Brand Devices [STABOLT]

• 03613720215547: SCREW REMOVER
• 03613720215530: U-JOINT SELF RETAINING SCREWDRIVER
• 03613720215509: SCREW HOLDER
• 03613720215493: U-JOINT SCREWDRIVER
• 03613720215486: SPHERICAL SCREWDRIVER
• 03613720215479: STRAIGHT SCREWDRIVER
• 03613720215462: SHAFT HOLDER
• 03613720215455: IMPLANT HOLDER
• 03613720215448: SCREW HOLDER
• 03613720210269: DETACHABLE HOLDER
• 03613720227410: STABOLT SCREW SH8 Ø 5.5mm/25mm
• 03613720215639: SHARED INSTRUMENTS STABOLT / ALIF S/A TRAY
• 03613720215622: STABOLT ALIF S/A O-BATCH CASE
• 03613720215608: TRIAL FOR 130° LUMBOSACRAL PLATE
• 03613720215592: TRIAL FOR 115° LUMBOSACRAL PLATE
• 03613720215585: TRIAL FOR 130° LUMBOSACRAL PLATE
• 03613720215578: TRIAL FOR 115° LUMBOSACRAL PLATE
• 03613720215561: TRIAL ATTACHMENT FOR 4-HOLE PLATE
• 03613720215554: PLATE ANGLE GAUGE
• 03613720215431: VASCULAR RETRACTOR
• 03613720215424: AWL
• 03613720215417: TEMPORY HOLDING PIN
• 03613720215400: SLEEVE FOR DRILL
• 03613720215394: DRILL GUIDE
• 03613720215387: U-JOINT DRILL
• 03613720215370: STRAIGHT DRILL
• 03613720193173: STABOLT SCREW SH8 Ø 6.5mm/40mm
• 03613720193166: STABOLT SCREW SH8 Ø 6.5mm/40mm
• 03613720193159: STABOLT SCREW SH8 Ø 6.5mm/35mm
• 03613720193142: STABOLT SCREW SH8 Ø 6.5mm/35mm
• 03613720193135: STABOLT SCREW SH8 Ø 6.5mm/30mm
• 03613720193128: STABOLT SCREW SH8 Ø 6.5mm/30mm
• 03613720193111: STABOLT SCREW SH8 Ø 6.5mm/25mm
• 03613720193104: STABOLT SCREW SH8 Ø 6.5mm/25mm
• 03613720193098: STABOLT SCREW SH8 Ø 6.5mm/20mm
• 03613720193081: STABOLT SCREW SH8 Ø 6.5mm/20mm
• 03613720193074: STABOLT SCREW SH8 Ø 5.5mm/40mm
• 03613720193067: STABOLT SCREW SH8 Ø 5.5mm/40mm
• 03613720193050: STABOLT SCREW SH8 Ø 5.5mm/35mm
• 03613720193043: STABOLT SCREW SH8 Ø 5.5mm/35mm
• 03613720193036: STABOLT SCREW SH8 Ø 5.5mm/30mm
• 03613720193029: STABOLT SCREW SH8 Ø 5.5mm/30mm
• 03613720193005: STABOLT SCREW SH8 Ø 5.5mm/25mm
• 03613720192992: STABOLT SCREW SH8 Ø 5.5mm/20mm
• 03613720192985: STABOLT SCREW SH8 Ø 5.5mm/20mm
• 03613720192978: 3 HOLES LUMBOSACRAL PLATE Size 6 at 130°
• 03613720192961: 3 HOLES LUMBOSACRAL PLATE Size 6 at 115°
• 03613720192954: 3 HOLES LUMBOSACRAL PLATE Size 5 at 130°
• 03613720192947: 3 HOLES LUMBOSACRAL PLATE Size 5 at 115°
• 03613720192930: 3 HOLES LUMBOSACRAL PLATE Size 4 at 130°