FDA.reportPublic FDA data

PLS

Primary DI
G463066394BK0
Brand
PLS
Company
BOXSPINE HOLDINGS, INC.
Model
06.6394B-K
Catalog number
06.6394B-K
Device description
Ø5.5 Polyaxial Pedicle Screw Non-Cannulated with Screw Cap Ø7.5 x 40mm (Violet)
Published
2025-06-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KWPAppliance, Fixation, Spinal Interlaminal
NKBThoracolumbosacral Pedicle Screw System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWPAppliance, Fixation, Spinal InterlaminalOrthopedic2
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G463066394BK0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Spinal bone screw, non-bioabsorbableA small, threaded, implantable rod with a screw head and drive intended for internal spinal fixation by being screwed into the spine to hold a correction/stabilization device (e.g., rod, plate, tether) to bone; it is made of a material that is not chemically degraded or absorbed via natural body processes (e.g., surgical steel, titanium alloy, carbon fibre). It is available in various types (e.g., pedicle or transfacet, with a slotted, cross, star, or polygonal drive), and is typically used to provide immobilization and stabilization of spinal segments in the treatment of spinal instabilities or deformities. A screw head adaptor intended to stabilize a rod may be included with the screw.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
126547906
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G463066361BK0PLS06.6361B-K06.6361B-K2025-06-12
G463066362BK0PLS06.6362B-K06.6362B-K2025-06-12
G463066363BK0PLS06.6363B-K06.6363B-K2025-06-12
G463066364BK0PLS06.6364B-K06.6364B-K2025-06-12
G463066365BK0PLS06.6365B-K06.6365B-K2025-06-12
G463066380BK0PLS06.6380B-K06.6380B-K2025-06-12
G463066381BK0PLS06.6381B-K06.6381B-K2025-06-12
G463066382BK0PLS06.6382B-K06.6382B-K2025-06-12
G463066383BK0PLS06.6383B-K06.6383B-K2025-06-12
G463066384BK0PLS06.6384B-K06.6384B-K2025-06-12
G463066393BK0PLS06.6393B-K06.6393B-K2025-06-12
G463066395BK0PLS06.6395B-K06.6395B-K2025-06-12
G463066396BK0PLS06.6396B-K06.6396B-K2025-06-12
G463066416BK0PLS06.6416B-K06.6416B-K2025-06-12
G463066417BK0PLS06.6417B-K06.6417B-K2025-06-12
G463066418BK0PLS06.6418B-K06.6418B-K2025-06-12
G463066419BK0PLS06.6419B-K06.6419B-K2025-06-12
G463066420BK0PLS06.6420B-K06.6420B-K2025-06-12
G463066421BK0PLS06.6421B-K06.6421B-K2025-06-12
G463066429B0PLS06.6429B06.6429B2025-06-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00643169465879MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-06-28
00643169465879MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NKB2026-06-28
00643169101296MSB VERTEX® Reconstruction SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-06-27
10889981441555VIRATASeaspine Orthopedics CorporationNKB2026-06-24
10889981441555VIRATASeaspine Orthopedics CorporationKWP2026-06-24
10889981441609VIRATASeaspine Orthopedics CorporationKWP2026-06-24
10889981441609VIRATASeaspine Orthopedics CorporationNKB2026-06-24
10889981441616VIRATASeaspine Orthopedics CorporationNKB2026-06-24
10889981441616VIRATASeaspine Orthopedics CorporationKWP2026-06-24
10889981441623VIRATASeaspine Orthopedics CorporationNKB2026-06-24
10889981441623VIRATASeaspine Orthopedics CorporationKWP2026-06-24
10889981441661VIRATASeaspine Orthopedics CorporationNKB2026-06-24
10889981441661VIRATASeaspine Orthopedics CorporationKWP2026-06-24
10889981065348MarinerSeaspine Orthopedics CorporationNKB2016-09-02
10889981065539MarinerSeaspine Orthopedics CorporationNKB2016-09-02
10889981065553MarinerSeaspine Orthopedics CorporationNKB2016-09-02
10889981065577MarinerSeaspine Orthopedics CorporationNKB2016-09-02
10889981065584MarinerSeaspine Orthopedics CorporationNKB2016-09-02
10889981065607MarinerSeaspine Orthopedics CorporationNKB2016-09-02
10889981065645MarinerSeaspine Orthopedics CorporationNKB2016-09-02
10889981065669MarinerSeaspine Orthopedics CorporationNKB2016-09-02
10889981065683MarinerSeaspine Orthopedics CorporationNKB2016-09-02
10889981065706MarinerSeaspine Orthopedics CorporationNKB2016-09-02
10889981065720MarinerSeaspine Orthopedics CorporationNKB2016-09-02
10889981065744MarinerSeaspine Orthopedics CorporationNKB2016-09-02
10889981065768MarinerSeaspine Orthopedics CorporationNKB2016-09-02
10889981065782MarinerSeaspine Orthopedics CorporationNKB2016-09-02
10889981065805MarinerSeaspine Orthopedics CorporationNKB2016-09-02
10889981065829MarinerSeaspine Orthopedics CorporationNKB2016-09-02
10889981065843MarinerSeaspine Orthopedics CorporationNKB2016-09-02