FDA.reportPublic FDA data

Aquila Anterior Cervical Plate Screw

Primary DI
09348215126261
Brand
Aquila Anterior Cervical Plate Screw
Company
SIGNATURE ORTHOPAEDICS PTY LTD
Model
131-16-8420
Published
2024-02-02
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
K181190000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181190000Pinehurst Anterior Cervical Plate SystemSignature Orthopaedics Pty, Ltd.2019-01-17KWQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09348215126261PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09348215126261093482151262619348215126261

GMDN Terms#

Term, Definition table
TermDefinition
Spinal fixation plate, non-bioabsorbableA small, implantable, non-customized sheet of solid material intended to be attached to the spine with screws for spinal immobilization; it is made of a material that is not chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). The device is typically used to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities (e.g., during anterior/posterior cervical, anterior/posterior lumbar, thoracolumbar, and occipital fixation procedures).

Sterilization Methods#

Method table
Method

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
00840466901035PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901042PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901059PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901066PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901073PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901080PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901097PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901103PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901110PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901127PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901141PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901158PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901165PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901172PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901479PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901486PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901493PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901509PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901516PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901523PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901530PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901547PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901554PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901561PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901578PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901585PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901592PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901608PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901615PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901622PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21