Stable-L Interbody System

GUDID B6785254340

STABLE-L BLADE BASE INTERBODY 36X28X10, 6 DEG

NEXUS SPINE, L.L.C.

Metallic spinal interbody fusion cage

Primary Device ID	B6785254340
NIH Device Record Key	81532f1b-29c4-4e09-88a8-7b1dd6833b20
Commercial Distribution Status	In Commercial Distribution
Brand Name	Stable-L Interbody System
Version Model Number	525434
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	false
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	36 Millimeter
Depth	28 Millimeter
Height	10 Millimeter
Width	36 Millimeter
Depth	28 Millimeter
Height	10 Millimeter
Width	36 Millimeter
Depth	28 Millimeter
Height	10 Millimeter
Width	36 Millimeter
Depth	28 Millimeter
Height	10 Millimeter
Width	36 Millimeter
Depth	28 Millimeter
Height	10 Millimeter
Width	36 Millimeter
Depth	28 Millimeter
Height	10 Millimeter
Width	36 Millimeter
Depth	28 Millimeter
Height	10 Millimeter
Width	36 Millimeter
Depth	28 Millimeter
Height	10 Millimeter
Width	36 Millimeter
Depth	28 Millimeter
Height	10 Millimeter
Width	36 Millimeter
Depth	28 Millimeter
Height	10 Millimeter
Width	36 Millimeter
Depth	28 Millimeter
Height	10 Millimeter
Width	36 Millimeter
Depth	28 Millimeter
Height	10 Millimeter
Width	36 Millimeter
Depth	28 Millimeter
Height	10 Millimeter
Width	36 Millimeter
Depth	28 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B6785254340 [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	true
Device Is Sterile	false

[B6785254340]

Moist Heat or Steam Sterilization

[B6785254340]

Moist Heat or Steam Sterilization

[B6785254340]

Moist Heat or Steam Sterilization

[B6785254340]

Moist Heat or Steam Sterilization

[B6785254340]

Moist Heat or Steam Sterilization

[B6785254340]

Moist Heat or Steam Sterilization

[B6785254340]

Moist Heat or Steam Sterilization

[B6785254340]

Moist Heat or Steam Sterilization

[B6785254340]

Moist Heat or Steam Sterilization

[B6785254340]

Moist Heat or Steam Sterilization

[B6785254340]

Moist Heat or Steam Sterilization

[B6785254340]

Moist Heat or Steam Sterilization

[B6785254340]

Moist Heat or Steam Sterilization

[B6785254340]

Moist Heat or Steam Sterilization

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

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