Stable-L Interbody System

GUDID B678525223S0

Stable- L Interbody 30mm x 28mm x 10mm, 6°

NEXUS SPINE, L.L.C.

Metallic spinal interbody fusion cage

• Primary Device ID: B678525223S0
• NIH Device Record Key: 8594db88-fae9-4306-ae8b-68f8a9c4c808
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Stable-L Interbody System
• Version Model Number: 525223s
• Company DUNS: 028137605
• Company Name: NEXUS SPINE, L.L.C.
• 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 Dimensions

• Height: 10 Millimeter
• Width: 30 Millimeter
• Depth: 28 Millimeter
• Height: 10 Millimeter
• Width: 30 Millimeter
• Depth: 28 Millimeter
• Height: 10 Millimeter
• Width: 30 Millimeter
• Depth: 28 Millimeter
• Height: 10 Millimeter
• Width: 30 Millimeter
• Depth: 28 Millimeter
• Height: 10 Millimeter
• Width: 30 Millimeter
• Depth: 28 Millimeter
• Height: 10 Millimeter
• Width: 30 Millimeter
• Depth: 28 Millimeter
• Height: 10 Millimeter
• Width: 30 Millimeter
• Depth: 28 Millimeter
• Height: 10 Millimeter
• Width: 30 Millimeter
• Depth: 28 Millimeter
• Height: 10 Millimeter
• Width: 30 Millimeter
• Depth: 28 Millimeter
• Height: 10 Millimeter
• Width: 30 Millimeter
• Depth: 28 Millimeter
• Height: 10 Millimeter
• Width: 30 Millimeter
• Depth: 28 Millimeter
• Height: 10 Millimeter
• Width: 30 Millimeter
• Depth: 28 Millimeter
• Height: 10 Millimeter
• Width: 30 Millimeter
• Depth: 28 Millimeter
• Height: 10 Millimeter
• Width: 30 Millimeter
• Depth: 28 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B678525223S0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K243934

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-09-08
• Device Publish Date: 2025-08-31

On-Brand Devices [Stable-L Interbody System]

• B678525487S0: STABLE-L BLADE BASE INTERBODY 32X26X13, 15 DEG
• B6785254870: STABLE-L BLADE BASE INTERBODY 32X26X13, 15 DEG
• B678525481S0: STABLE-L BLADE BASED INTERBODY 41X31X18, 18 DEG
• B6785254810: STABLE-L BLADE BASED INTERBODY 41X31X18, 18 DEG
• B678525480S0: STABLE-L BLADE BASED INTERBODY 41X31X18, 18 DEG
• B6785254800: STABLE-L BLADE BASED INTERBODY 41X31X18, 18 DEG
• B678525479S0: STABLE-L BLADE BASED INTERBODY 41X31X16, 18 DEG
• B6785254790: STABLE-L BLADE BASED INTERBODY 41X31X16, 18 DEG
• B678525478S0: STABLE-L BLADE BASED INTERBODY 41X31X14, 18 DEG
• B6785254780: STABLE-L BLADE BASED INTERBODY 41X31X14, 18 DEG
• B678525477S0: STABLE-L BLADE BASED INTERBODY 41X31X18, 12 DEG
• B6785254770: STABLE-L BLADE BASED INTERBODY 41X31X18, 12 DEG
• B678525476S0: STABLE-L BLADE BASED INTERBODY 41X31X18, 12 DEG
• B6785254760: STABLE-L BLADE BASED INTERBODY 41X31X18, 12 DEG
• B678525475S0: STABLE-L BLADE BASED INTERBODY 41X31X16, 12 DEG
• B6785254750: STABLE-L BLADE BASED INTERBODY 41X31X16, 12 DEG
• B678525474S0: STABLE-L BLADE BASED INTERBODY 41X31X14, 12 DEG
• B6785254740: STABLE-L BLADE BASED INTERBODY 41X31X14, 12 DEG
• B678525473S0: STABLE-L BLADE BASED INTERBODY 41X31X12, 12 DEG
• B6785254730: STABLE-L BLADE BASED INTERBODY 41X31X12, 12 DEG
• B678525472S0: STABLE-L BLADE BASED INTERBODY 41X31X18, 6 DEG
• B6785254720: STABLE-L BLADE BASED INTERBODY 41X31X18, 6 DEG
• B678525471S0: STABLE-L BLADE BASED INTERBODY 41X31X16, 6 DEG
• B6785254710: STABLE-L BLADE BASED INTERBODY 41X31X16, 6 DEG
• B678525470S0: STABLE-L BLADE BASED INTERBODY 41X31X14, 6 DEG
• B6785254700: STABLE-L BLADE BASED INTERBODY 41X31X14, 6 DEG
• B678525469S0: STABLE-L BLADE BASED INTERBODY 41X31X12, 6 DEG
• B6785254690: STABLE-L BLADE BASED INTERBODY 41X31X12, 6 DEG
• B678525468S0: STABLE-L BLADE BASED INTERBODY 41X31X10, 6 DEG
• B6785254680: STABLE-L BLADE BASED INTERBODY 41X31X10, 6 DEG
• B678525467S0: STABLE-L BLADE BASE INTERBODY 36X31X20, 18 DEG
• B6785254670: STABLE-L BLADE BASE INTERBODY 36X31X20, 18 DEG
• B678525466S0: STABLE-L BLADE BASE INTERBODY 36X31X18, 18 DEG
• B6785254660: STABLE-L BLADE BASE INTERBODY 36X31X18, 18 DEG
• B678525465S0: STABLE-L BLADE BASE INTERBODY 36X31X16, 18 DEG
• B6785254650: STABLE-L BLADE BASE INTERBODY 36X31X16, 18 DEG
• B678525464S0: STABLE-L BLADE BASE INTERBODY 36X31X14, 18 DEG
• B6785254640: STABLE-L BLADE BASE INTERBODY 36X31X14, 18 DEG
• B678525463S0: STABLE-L BLADE BASE INTERBODY 36X31X20, 12 DEG
• B6785254630: STABLE-L BLADE BASE INTERBODY 36X31X20, 12 DEG
• B678525462S0: STABLE-L BLADE BASE INTERBODY 36X31X18, 12 DEG
• B6785254620: STABLE-L BLADE BASE INTERBODY 36X31X18, 12 DEG
• B678525461S0: STABLE-L BLADE BASE INTERBODY 36X31X16, 12 DEG
• B6785254610: STABLE-L BLADE BASE INTERBODY 36X31X16, 12 DEG
• B678525460S0: STABLE-L BLADE BASE INTERBODY 36X31X14, 12 DEG
• B6785254600: STABLE-L BLADE BASE INTERBODY 36X31X14, 12 DEG
• B678525459S0: STABLE-L BLADE BASE INTERBODY 36X31X12, 12 DEG
• B6785254590: STABLE-L BLADE BASE INTERBODY 36X31X12, 12 DEG
• B678525458S0: STABLE-L BLADE BASE INTERBODY 36X31X20, 6 DEG
• B6785254580: STABLE-L BLADE BASE INTERBODY 36X31X20, 6 DEG