FDA.report

Stable-C

Primary DI
B6788232490
Brand
Stable-C
Company
NEXUS SPINE, L.L.C.
Model
823249
Device description
Stable-C Implant Caddy 14x12
Published
2023-11-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
FSMTray, Surgical, Instrument

Product Code Classifications

CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B678823249Direct MarkingHIBCC0
B6788232490PrimaryHIBCC0

GMDN Terms

TermDefinition
Instrument tray, reusableA container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure; it might, in addition, be used during, but not dedicated to, reprocessing/sterilization procedures. It is a receptacle in one of a variety of designs, typically with moulded positions for placing the instruments; it might include a lid and/or removable identification tags. This is a reusable 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

Other Devices From This Company

Primary DIBrandModelCatalogPublished
B678522023S0Tranquil-L Interbody System522023s2026-01-05
B678522024S0Tranquil-L Interbody System522024s2026-01-05
B678522025S0Tranquil-L Interbody System522025s2026-01-05
B678522026S0Tranquil-L Interbody System522026s2026-01-05
B678522027S0Tranquil-L Interbody System522027s2026-01-05
B678522028S0Tranquil-L Interbody System522028s2026-01-05
B678522029S0Tranquil-L Interbody System522029s2026-01-05
B678522030S0Tranquil-L Interbody System522030s2026-01-05
B678522031S0Tranquil-L Interbody System522031s2026-01-05
B678522032S0Tranquil-L Interbody System522032s2026-01-05
B678522033S0Tranquil-L Interbody System522033s2026-01-05
B678522902S0Tranquil-L Interbody System522902s2026-01-05
B678522903S0Tranquil-L Interbody System522903s2026-01-05
B678520215S0PressON Pedicle Screw System520215S2025-12-31
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
B678520221S0PressON Pedicle Screw System520221S2025-12-31

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
07898663491562HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07898663493108HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07898663493467HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07898663495263HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07898663495270HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07898663495751HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07898663496239HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07898663497267HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07898663498080HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07898663498097HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07898663499292HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07898663499926HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07898663499957HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07898663499971HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07901089802307HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07901089803113HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07901089803441HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07901089804349HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07901089804950HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07901089806367HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07901089806626HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07901089807012HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07901089807029HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07901089807999HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07901089808583HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07901089808682HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07901089808729HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07901089809511HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07901089809528HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07901089809535HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24