FDA.report

Stable-L™

Primary DI
B6788251790
Brand
Stable-L™
Company
NEXUS SPINE, L.L.C.
Model
825179
Device description
Stable-L Angled Punch
Published
2023-02-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
LXHOrthopedic Manual Surgical Instrument
OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar

Product Code Classifications

CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1
OVDIntervertebral Fusion Device With Integrated Fixation, LumbarOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B678825179Direct MarkingHIBCC0
B6788251790PrimaryHIBCC0

GMDN Terms

TermDefinition
Metallic spinal interbody fusion cageA device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is in the form of a hollow, porous, threaded and/or fenestrated cylindrical or geometrical device made of metal [e.g., titanium (Ti)] that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be included with the device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
028137605
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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B678522025S0Tranquil-L Interbody System522025s2026-01-05
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B678522032S0Tranquil-L Interbody System522032s2026-01-05
B678522033S0Tranquil-L Interbody System522033s2026-01-05
B678522902S0Tranquil-L Interbody System522902s2026-01-05
B678522903S0Tranquil-L Interbody System522903s2026-01-05
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B678520216S0PressON Pedicle Screw System520216S2025-12-31
B678520217S0PressON Pedicle Screw System520217S2025-12-31
B678520218S0PressON Pedicle Screw System520218S2025-12-31
B678520219S0PressON Pedicle Screw System520219S2025-12-31
B678520220S0PressON Pedicle Screw System520220S2025-12-31
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