FDA.reportPublic FDA data

TYPHOON™Facet Screw Fixation System

Primary DI
00840996146647
Brand
TYPHOON™Facet Screw Fixation System
Company
Choice Spine, LP
Model
SPCL-K001
Device description
SPCL,TYPHOON,DRILL GUIDE
Published
2017-01-21
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
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K121850000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K121850000Typhoon(TM) Facet Screw Fixation SystemChoicespine, LP2012-09-20MRW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840996146647PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840996146647008409961466478409961466470840996146647

GMDN Terms#

Term, Definition table
TermDefinition
Trans-facet-screw internal spinal fixation system, sterileA sterile device assembly that consists of rods, plates, and facet fixation screws where the screws are inserted bilaterally through and across the facet joint (spinal joint), i.e., trans-facet, at a single or multiple levels to stabilize and fuse vertebrae with compression in the treatment of various spinal conditions.

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
00810130207541MSIModern Surgical Instruments LLCLXH2026-09-24
00810130207558MSIModern Surgical Instruments LLCLXH2026-09-24
00840606185929PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606185936PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606186773PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606186780PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606187237PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606187244PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606187251PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00885556854778Cadence Total Ankle SystemSmith & Nephew, Inc.LXH2026-09-24
07899258601670Orthopedic InstrumentsGM DOS REIS INDUSTRIA E COMERCIO LTDALXH2026-09-24
00840606174923PrimusSPINAL ELEMENTS, INC.LXH2026-09-22
B7685215250Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2026-06-19
B7683434130Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2026-04-23
B7685216220Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-11-13
B7685111560Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-11-03
B768521135180Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-11-03
B7685216060Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-11-03
B7685231490Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-11-03
B7685283430Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-11-03
B7682460370Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-09-24
B7682440010Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-06-20
B7682459240Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-05-30
B7682460080Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-05-30
B7682459260Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-03-27
B768345211500Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-03-27
B7685118310Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-03-27
B7685211080Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-03-27
B7685215150Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-03-27
B7685271430Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-03-27