Optimus

GUDID 00840916129248

Optimus PEEK End Cap 25 x 32, 3deg - B

SPINAL ELEMENTS

Polymeric spinal interbody fusion cage

• Primary Device ID: 00840916129248
• NIH Device Record Key: 28c2afd4-64ec-41f0-af8d-de17871eb982
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Optimus
• Version Model Number: 131203
• Company DUNS: 004022104
• Company Name: SPINAL ELEMENTS
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840916129248 [Primary]

FDA Product Code

• OVD: Intervertebral Fusion Device With Integrated Fixation, Lumbar

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: 2020-02-24
• Device Publish Date: 2017-07-05

On-Brand Devices [Optimus]

• 00840916129323: Optimus PEEK End Cap 29 x 36, 7deg - B
• 00840916129316: Optimus PEEK End Cap 29 x 36, 5deg - B
• 00840916129309: Optimus PEEK End Cap 29 x 36, 3deg - B
• 00840916129293: Optimus PEEK End Cap 29 x 36, 7deg - A
• 00840916129286: Optimus PEEK End Cap 29 x 36, 5deg - A
• 00840916129279: Optimus PEEK End Cap 29 x 36, 3deg - A
• 00840916129262: Optimus PEEK End Cap 25 x 32, 7deg - B
• 00840916129255: Optimus PEEK End Cap 25 x 32, 5deg - B
• 00840916129248: Optimus PEEK End Cap 25 x 32, 3deg - B
• 00840916129231: Optimus PEEK End Cap 25 x 32, 7deg - A
• 00840916129224: Optimus PEEK End Cap 25 x 32, 5deg - A
• 00840916129217: Optimus PEEK End Cap 25 x 32, 3deg - A
• 00840916129354: Optimus Screw 32mm
• 00840916129347: Optimus Screw 28mm
• 00840916129330: Optimus Screw 24mm
• 00840916129200: Optimus Anterior Lumbar Plate 29 x 36, 13mm
• 00840916129194: Optimus Anterior Lumbar Plate 29 x 36, 12mm
• 00840916129187: Optimus Anterior Lumbar Plate 29 x 36, 11mm
• 00840916129170: Optimus Anterior Lumbar Plate 29 x 36, 10mm
• 00840916129163: Optimus Anterior Lumbar Plate 29 x 36, 9mm
• 00840916129156: Optimus Anterior Lumbar Plate 25 x 32, 13mm
• 00840916129149: Optimus Anterior Lumbar Plate 25 x 32, 12mm
• 00840916129132: Optimus Anterior Lumbar Plate 25 x 32, 11mm
• 00840916129125: Optimus Anterior Lumbar Plate 25 x 32, 10mm
• 00840916129118: Optimus Anterior Lumbar Plate 25 x 32, 9mm
• 00840916151010: ASSEMBLED U-JOINT LINKAGE
• 00840916151003: FIXED ANGLE LINK DRIVER OUTER
• 00840916148096: FIXED ANGLE LINK DRIVER