FDA.reportPublic FDA data

Dyna Locking Cannulated Screw

Primary DI
08800037585165
Brand
Dyna Locking Cannulated Screw
Company
CG MedTech Co.,Ltd.
Model
IC1005
Published
2024-01-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HTOREAMER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTOReamerOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800037585165PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800037585165088000375851658800037585165

GMDN Terms#

Term, Definition table
TermDefinition
Cannulated surgical drill bit, reusableA shaft of metal intended to be mounted into an appropriate surgical power tool (e.g., a pneumatic reamer or drilling system handpiece with appropriate torque capacity) and rotated to bore into hard/tough tissues (e.g., bone, cartilage) to clear a channel of the same dimension as the diameter of the shaft. This drill is cannulated, having a hollow centre, and is typically flexible so that it can be fed over a guiding pin that has been placed into the correct position prior to operation. This device is typically used in orthopaedic surgery for clearing of the intramedullary channel prior to the insertion of a prosthetic device. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
688811082
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800308485811ANAX™ OCT SPINAL SYSTEMOSS07502026-05-13
08800037574725Velofix™ SA Cervical CageTS09122026-05-06
08800037574732Velofix™ SA Cervical CageTS09132026-05-06
08800308485804ANAX™ OCT Spinal SystemOS00902026-04-21
08800247357477SECULOK™ ACP SYSTEMFCA10192026-03-31
08800247357484SECULOK™ ACP SYSTEMFCA10212026-03-31
08800247357491SECULOK™ ACP SYSTEMFCA10232026-03-31
08800247357507SECULOK™ ACP SYSTEMFCA10252026-03-31
08800247357514SECULOK™ ACP SYSTEMFCA10272026-03-31
08800247357521SECULOK™ ACP SYSTEMFCA10292026-03-31
08800247357538SECULOK™ ACP SYSTEMFCA10312026-03-31
08800247357545SECULOK™ ACP SYSTEMFCA10332026-03-31
08800247357552SECULOK™ ACP SYSTEMFCA10352026-03-31
08800247357569SECULOK™ ACP SYSTEMFCA10372026-03-31
08800247357576SECULOK™ ACP SYSTEMFCA10392026-03-31
08800247357583SECULOK™ ACP SYSTEMFCA10412026-03-31
08800247357590SECULOK™ ACP SYSTEMFCA10432026-03-31
08800247357606SECULOK™ ACP SYSTEMFCA10452026-03-31
08800247357613SECULOK™ ACP SYSTEMFCA20312026-03-31
08800247357620SECULOK™ ACP SYSTEMFCA20332026-03-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10885862663207N/AExactech, Inc.HTO2026-05-28
08059386748701Orthopaedic Surgical InstrumentsCITIEFFE SRLHTO2026-05-27
08800017270265BENCOXCorentec Co., LtdHTO2026-04-02
08800017270272BENCOXCorentec Co., LtdHTO2026-04-02
08800017270289BENCOXCorentec Co., LtdHTO2026-04-02
08800017270296BENCOXCorentec Co., LtdHTO2026-04-02
08800017270302BENCOXCorentec Co., LtdHTO2026-04-02
08800017270319BENCOXCorentec Co., LtdHTO2026-04-02
08800017270326BENCOXCorentec Co., LtdHTO2026-04-02
08800017270333BENCOXCorentec Co., LtdHTO2026-04-02
08800017270340BENCOXCorentec Co., LtdHTO2026-04-02
08800017270364BENCOXCorentec Co., LtdHTO2026-04-02
08800017270388BENCOXCorentec Co., LtdHTO2026-04-02
08800017270401BENCOXCorentec Co., LtdHTO2026-04-02
08800017270425BENCOXCorentec Co., LtdHTO2026-04-02
08800017270449BENCOXCorentec Co., LtdHTO2026-04-02
08800017270463BENCOXCorentec Co., LtdHTO2026-04-02
08800017270470BENCOXCorentec Co., LtdHTO2026-04-02
08800017270487BENCOXCorentec Co., LtdHTO2026-04-02
08800017270500BENCOXCorentec Co., LtdHTO2026-04-02
08800017270524BENCOXCorentec Co., LtdHTO2026-04-02
08800017270548BENCOXCorentec Co., LtdHTO2026-04-02
08800017270562BENCOXCorentec Co., LtdHTO2026-04-02
08800017270579BENCOXCorentec Co., LtdHTO2026-04-02
08800017270586BENCOXCorentec Co., LtdHTO2026-04-02
08800017270593BENCOXCorentec Co., LtdHTO2026-04-02
08800017270609BENCOXCorentec Co., LtdHTO2026-04-02
08800017270616BENCOXCorentec Co., LtdHTO2026-04-02
08800017270623BENCOXCorentec Co., LtdHTO2026-04-02
07640187918410TRIGEN MAX ENTRY REAMER 12.5 MM, HALL-JACOBSMPS Micro Precision Systems AGHTO2026-02-24