Sagittae 903-030-XX

GUDID 00819837021085

MIS Handle

SPINEEX, INC.

Surgical instrument handle, non-torque-limiting

• Primary Device ID: 00819837021085
• NIH Device Record Key: b294b843-a385-41c6-8d23-5684b3eb447e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sagittae
• Version Model Number: 903-030-XX
• Catalog Number: 903-030-XX
• Company DUNS: 080723590
• Company Name: SPINEEX, 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: false
• Lot Batch: true
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 5135736165
• Email: info@spineexinc.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00819837021085 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200816

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

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

[00819837021085]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-05-22
• Device Publish Date: 2020-05-14

On-Brand Devices [Sagittae]

• 00819837020132: Slap hammer
• 00819837020071: Inserter
• 00819837020996: Sagittae Independent Driver, SHORT, 465 SST
• 00819837020941: Sagittae Independent Driver, SHORT, 440B SST
• 00819837020781: Sagittae Independent Driver, LONG, 440B SST
• 00819837020545: Sagittae Independent Driver, LONG, 465 SST
• 00819837021146: Lateral Lumbar Interbody Fusion Device Instruments, Spare Case: Sagittae Trial, Sagittae Indepen
• 00819837020989: Torque Limiting Handle,162mm 1/4" SQ ADPT, Ratchet, Sagittae, Inserter, 3.00 Nm, Green
• 00819837020965: Torque Limiting Handle, 162mm 1/4" SQ ADPT, Ratchet, Sagittae, Inserter, 2.75 Nm, Green
• 00819837020934: Torque Limiting Handle, 162mm, 1/4" SQ ADPT, Ratchet, Sagittae, Inserter, 2.50 Nm, Green
• 00819837020927: Torque Limiting Handle, 162mm 1/4" SQ ADPT, Ratchet, Sagittae, Inserter, 2.25 Nm, Green
• 00819837020903: Torque Limiting Handle, 162mm 1/4" SQ ADPT, Ratchet, Sagittae, Inserter, 2.00 Nm, Green
• 00819837020743: Torque Limiting Handle,162mm 1/4" SQ ADPT, Ratchet, Sagittae, Inserter, 3.00 Nm, Blue
• 00819837020705: Torque Limiting Handle,162mm 1/4" SQ ADPT, Ratchet, Sagittae, Inserter, 2.75 Nm, Blue
• 00819837020668: Torque Limiting Handle, 162mm, 1/4" SQ ADPT, Ratchet, Sagittae, Inserter, 2.50 Nm, Blue
• 00819837020620: Torque Limiting Handle, 162mm 1/4" SQ ADPT, Ratchet, Sagittae, Inserter, 2.25 Nm, Blue
• 00819837020583: Torque Limiting Handle, 162mm 1/4" SQ ADPT, Ratchet, Sagittae, Inserter, 2.00 Nm, Blue
• 00819837020057: Lateral Lumbar Interbody Fusion Device 58.0 mm length x 21.5 mm width x 8.4 mm-17.1 mm height, 0
• 00819837020040: Lateral Lumbar Interbody Fusion Device 54.0 mm length x 21.5 mm width x 8.4 mm-17.1 mm height, 0
• 00819837020033: Lateral Lumbar Interbody Fusion Device 50.0 mm length x 21.5 mm width x 8.4 mm-17.1 mm height, 0
• 00819837020026: Lateral Lumbar Interbody Fusion Device 46.0 mm length x 21.5 mm width x 8.4 mm-17.1 mm height, 0
• 00819837020019: Lateral Lumbar Interbody Fusion Device 42.0 mm length x 21.5 mm width x 8.4 mm-17.1 mm height, 0
• 00819837020507: Naked-Driver, 440C SST
• 00819837020446: Torque Limiting Handle, 1/4" SQ ADPT, Ratchet, Sagittae, Inserter, 2.25 Nm
• 00819837020231: Trial, 8.4 mm Height
• 00819837020224: Torque Limiting Handle, 1/4" SQ ADPT, Ratchet, Sagittae, Inserter, 3.00 Nm
• 00819837020217: Torque Limiting Handle, 1/4" SQ ADPT, Ratchet, Sagittae, Inserter, 2.50 Nm
• 00819837020200: Torque Limiting Handle, 1/4" SQ ADPT, Ratchet, Sagittae, Inserter, 2.75 Nm
• 00819837020194: Torque Limiting Handle, 1/4" SQ ADPT, Ratchet, Sagittae, Inserter, 2.00 Nm
• 00819837020101: Bone Graft Delivery System
• 00819837020095: Trial, 6.9 mm Height
• 00819837020088: Trial, 5.4 mm Height
• 00819837020064: Lateral Lumbar Interbody Fusion Device Inserter Case: Sagittae Inserter, Sagittae Bone Graft Del
• 00819837021245: Inserter Case
• 00819837021221: Bone Graft Delivery System, 30 cc
• 00819837021207: Bone Graft Containment Slide, 22 mm
• 00819837021122: Short Inserter, SST
• 00819837021108: Long Inserter, SST
• 00819837021085: MIS Handle
• 00819837021061: Trial, 16 mm Height
• 00819837021047: Trial, 15 mm Height
• 00819837021023: Trial, 14 mm Height
• 00819837020880: Trial, 13 mm Height
• 00819837020866: Trial, 12 mm Height
• 00819837020842: Trial, 11 mm Height
• 00819837020828: Trial, 10 mm Height
• 00819837020804: Trial, 9 mm Height
• 00819837020361: Short Inserter, AL
• 00819837020309: Long Inserter, AL
• 00819837021320: Torque Limiting Handle,162mm 1/4" SQ ADPT, Ratchet, Sagittae, Inserter, 3.15 Nm, Green