FDA.reportPublic FDA data

FALCON™ Anterior Cervical Plate

Primary DI
00840996131520
Brand
FALCON™ Anterior Cervical Plate
Company
Choice Spine, LP
Model
A070-0012
Device description
FALCON,AWL
Published
2016-05-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWJAWL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWJAwlOrthopedic1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K091926000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K091926000CHOICE SPINE ANTERIOR CERVICAL PLATE (ACP) SYSTEMChoicespine, LP2009-12-22KWQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840996131520PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840996131520008409961315208409961315200840996131520

GMDN Terms#

Term, Definition table
TermDefinition
Spinal fixation plate, non-bioabsorbableA small implantable sheet of solid material that is attached to the spine with screws for spinal immobilization and 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
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(865)246-3333info@choicespine.net

Regulatory Flags#

DUNS number
078293017
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840996183154Ambassador05-109-18-00272023-02-03
00810211101256THUNDERBOLTM070-02312026-02-13
00840996176552BOOMERANGBT20-D45132026-01-15
00840996176569BOOMERANGBT20-D45152026-01-15
00840996176576BoomerangBT20-D45172026-01-15
00840996176583BOOMERANGB070-00002026-01-15
00840996176590BOOMERANGB070-D0102026-01-15
00840996176606BoomerangB070-00012026-01-15
00840996176392VEo LateralV070-00902022-11-16
00840996176408VEo LateralV070-00912022-11-16
00840996176415VEo LateralV070-00922022-11-16
00840996176422VEo LateralV070-00932022-11-16
00840996176125TiGER SHARK Interbody Fusion SystemS-PT36-240962019-01-05
00840996176132TiGER SHARK Interbody Fusion SystemS-PT36-241062019-01-05
00840996176149TiGER SHARK Interbody Fusion SystemS-PT36-241162019-01-05
00840996176156TiGER SHARK Interbody Fusion SystemS-PT36-241262019-01-05
00840996176163TiGER SHARK Interbody Fusion SystemS-PT36-241362019-01-05
00840996176170TiGER SHARK Interbody Fusion SystemS-PT36-241462019-01-05
00840996176187TiGER SHARK Interbody Fusion SystemS-PT36-241562019-01-05
00840996176194TiGER SHARK Interbody Fusion SystemS-PT36-241662019-01-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840311245376Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.HWJ2026-04-30
00860015151308EnFix Instrument Kit - CompleteTETROUS, INC.HWJ2026-02-24
00887868287473Trinica ALP Anterior Lumbar Plate SystemHighridge Medical, LLCHWJ2025-11-12
03662663108126Trinica/Trinica Select Anterior Cervical Plate SystemHighridge Medical, LLCHWJ2025-11-12
03662663109949InViZia Anterior Cervical Plate SystemHighridge Medical, LLCHWJ2025-11-12
03662663128759PathFinder NXT Minimally Invasive Pedicle Screw SystemHighridge Medical, LLCHWJ2025-11-12
03662663129015Lineum Occipito-Cervico-Thoracic (OCT) Spinal Fixation SystemHighridge Medical, LLCHWJ2025-11-12
07640375234773SCARLET AL-T INSTRUMENTATIONSpineArt SAHWJ2025-11-10
08059386744338Orthopaedic Surgical InstrumentsCITIEFFE SRLHWJ2025-11-06
00763000674410n/aMEDTRONIC SOFAMOR DANEK, INC.HWJ2025-10-26
09120129291507Awl, Curved, CannulatedI.T.S. GmbHHWJ2025-10-21
09120129291514Awl TrocarI.T.S. GmbHHWJ2025-10-21
00763000878245n/aMEDTRONIC SOFAMOR DANEK, INC.HWJ2025-10-20
00840180541050General InstrumentsALPHATEC SPINE, INC.HWJ2025-10-17
00763000885243n/aMEDTRONIC SOFAMOR DANEK, INC.HWJ2025-10-11
00816342025522AWLPARCUS MEDICAL LLCHWJ2025-09-16
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00841732142336GENERIC Surgical InstrumentsCTL Medical CorporationHWJ2025-03-31
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00841732139411GENERIC Surgical InstrumentsCTL Medical CorporationHWJ2023-10-07
00841732139428GENERIC Surgical InstrumentsCTL Medical CorporationHWJ2023-10-07
00841732163850GENERIC Surgical InstrumentsCTL Medical CorporationHWJ2023-09-14