NAMBUCCA Anterior Lumbar Plate Screw

Primary DI
09348215020002
Brand
NAMBUCCA Anterior Lumbar Plate Screw
Company
SIGNATURE ORTHOPAEDICS PTY LTD
Model
PS1-10-1828
Published
2017-08-25
Public version status
Update
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
KWQAppliance, Fixation, Spinal Intervertebral Body

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K163625000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K163625000NOOSA Anterior Lumbar Plate System;NAMBUCCA Anterior Lumbar Plate System; CAIRNS Anterior Lumbar Plate SystemSignature Orthopaedics Pty, Ltd.2017-08-11KWQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09348215020002PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09348215020002093482150200029348215020002

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw, non-bioabsorbable, sterile"A small, sterile, threaded rod with a slotted head typically used for internal orthopaedic fracture fixation by being screwed into bone to hold plates or nails to bone or to provide direct interfragmentary stabilization of bone, or it may fasten soft tissue to bone; it is made of a material that cannot be chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). There are a number of kinds available: cortical, cancellous, malleolar, scaphoid, partially-threaded and fully-threaded, self-tapping, and cannulated. A ""lag screw"" can be any of these used to obtain compression across bone fragments."

Regulatory Flags#

DUNS number
751993028
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09348215019587Evolve AP Cup - Size 28-40111-17-40282026-06-26
09348215019594Evolve AP Cup - Size 28-42111-17-42282026-06-26
09348215019600Evolve AP Cup - Size 28-44111-17-44282026-06-26
09348215019617Evolve AP Cup - Size 28-46111-17-46282026-06-26
09348215019624Evolve AP Cup - Size 28-48111-17-48282026-06-26
09348215019631Evolve AP Cup - Size 28-50111-17-50282026-06-26
09348215019648Evolve AP Cup - Size 28-52111-17-52282026-06-26
09348215019655Evolve AP Cup - Size 28-54111-17-54282026-06-26
09348215019662Evolve AP Cup - Size 28-56111-17-56282026-06-26
09348215046019World Knee Cemented Titanium Tibial Plate - Modular - Size 1 - 40mm121-20-41202026-06-26
09348215046026World Knee Cemented Titanium Tibial Plate - Modular - Size 2 - 40mm121-20-42202026-06-26
09348215046033World Knee Cemented Titanium Tibial Plate - Modular - Size 3 - 40mm121-20-43202026-06-26
09348215046040World Knee Cemented Titanium Tibial Plate - Modular - Size 4 - 40mm121-20-44202026-06-26
09348215046057World Knee Cemented Titanium Tibial Plate - Modular - Size 5 - 40mm121-20-45202026-06-26
09348215046064World Knee Cemented Titanium Tibial Plate - Modular - Size 6 - 40mm121-20-46202026-06-26
09348215046071World Knee Cemented Titanium Tibial Plate - Modular - Size 7 - 40mm121-20-47202026-06-26
09348215046088World Knee Cemented Titanium Tibial Plate - Modular - Size 8 - 40mm121-20-48202026-06-26
09348215046095World Knee Cemented Titanium Tibial Plate - Modular - Size 9 - 40mm121-20-49202026-06-26
09348215148980Evolve AP Vit-E Cup – Neutral - Size 32-46111-17-01462026-06-26
09348215148997Evolve AP Vit-E Cup – Neutral - Size 32-48111-17-01482026-06-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840493424712RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424729RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424736RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424743RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424750RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424767RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424774RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424781RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424798RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424804RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424811RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424828RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424835RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424842RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424859RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424866RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424873RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424880RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424897RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424903RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424910RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424927RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424934RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424941RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424958RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424965RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424972RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424989RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424996RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493425009RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13