FDA.reportPublic FDA data

NA

Primary DI
10886982203700
Brand
NA
Company
Synthes GmbH
Model
400.810.96
Catalog number
40081096
Device description
1.5MM TI CORTEX SCREW SELF-TAPPING 10MM
Published
2015-09-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DZLSCREW, FIXATION, INTRAOSSEOUS
MQNEXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZLScrew, Fixation, IntraosseousDental2
MQNExternal Mandibular Fixator And/Or DistractorDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K980199000
K981275000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K980199000SYNTHES 1.5MM/2.0MM ORTHOGNATHIC MAXILLARY PLATES AND SCREWSSynthes (Usa)1998-04-17DZL
K981275000SYNTHES (USA) RATCHETING DISTRACTORSynthes (Usa)1998-06-25MQN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10886982203700PrimaryGS10
H679400810960SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088698220370010886982203700

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw (non-sliding)A small, threaded, non-bioabsorbable, implantable rod intended for internal orthopaedic fixation by being screwed into a limb bone, rib, the sternum and/or pelvis to hold a plate, nail, rod or prosthesis to the bone, or to provide direct interfragmentary stabilization of a fractured bone; it is not intended to be introduced through the sleeve of a femoral neck fixation plate/sleeve, not used in dentistry/orthodontics, craniofacial or spinal bones, and not dedicated to intramedullary fixation/arthrodesis. It is typically of cortical or cancellous design and has a drive (e.g., slot, cross, star, polygonal) at its proximal end for introduction with a screwdriver.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
486711679
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10705034717081Zero-P03.617.792036177922015-09-14
10705034717098Zero-P03.617.795036177952015-09-14
10705034717203NA03.617.907036179072015-09-14
10705034722634NA03.804.512S03804512S2019-08-10
10705034731841NA03.820.159S03820159S2019-08-10
10705034736075USS04.607.038046070382015-09-14
10705034742199Zero-P04.617.232S04617232S2015-09-14
10705034754444OPAL08.803.114088031142015-09-14
10705034754468OPAL08.803.116088031162015-09-14
10705034754529OPAL08.803.134088031342015-09-14
10705034754611OPAL08.803.214088032142015-09-14
10705034754635OPAL08.803.216088032162015-09-14
10705034754697OPAL08.803.234088032342015-09-14
10705034754741VERTEBRAL SPACER-TR08.804.037088040372015-09-14
10705034754765VERTEBRAL SPACER-TR08.804.039088040392015-09-14
10705034754826VERTEBRAL SPACER-TR08.804.047088040472015-09-14
10705034762852ACIS08.843.805088438052015-09-14
10705034762876ACIS08.843.806088438062015-09-14
10705034762890ACIS08.843.807088438072015-09-14
10705034762913ACIS08.843.808088438082015-09-14

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08800089458936Leforte MMF SystemJeil Medical CorporationDZL2026-04-09
08800089458943Leforte MMF SystemJeil Medical CorporationDZL2026-04-09
08800089458950Leforte MMF SystemJeil Medical CorporationDZL2026-04-09
08800089458967Leforte MMF SystemJeil Medical CorporationDZL2026-04-09
08800089458974Leforte MMF SystemJeil Medical CorporationDZL2026-04-09
08800089458981Leforte MMF SystemJeil Medical CorporationDZL2026-04-09
08800089458998Leforte MMF SystemJeil Medical CorporationDZL2026-04-09
08800089459001Leforte MMF SystemJeil Medical CorporationDZL2026-04-09
ESAM23053121STOMA®Storz am Mark GmbHDZL2025-04-30
ESAM23060091STOMA® micro-screwStorz am Mark GmbHDZL2024-01-12
ESAM23060111STOMA® micro-screwStorz am Mark GmbHDZL2024-01-12
ESAM23060131STOMA® micro-screwStorz am Mark GmbHDZL2024-01-12
ESAM23061091STOMA® micro-screwStorz am Mark GmbHDZL2024-01-12
ESAM23061111STOMA® micro-screwStorz am Mark GmbHDZL2024-01-12
ESAM23061131STOMA® micro-screwStorz am Mark GmbHDZL2024-01-12
ESAM21221001STOMA®Storz am Mark GmbHDZL2023-06-19
ESAM23053141STOMA®Storz am Mark GmbHDZL2023-06-19
ESAM23048001STOMA®Storz am Mark GmbHDZL2020-11-09
ESAM23049001STOMA®Storz am Mark GmbHDZL2020-08-27
08806390878029Jeil Bone Fixation SystemJeil Medical CorporationDZL2019-06-18
10810004515700CMF VISIONAREVISIONARE, LLCDZL2019-02-21
10810004515748CMF VISIONAREVISIONARE, LLCDZL2019-02-21
10810004515755CMF VISIONAREVISIONARE, LLCDZL2019-02-21
10810004515762CMF VISIONAREVISIONARE, LLCDZL2019-02-21
10810004515779CMF VISIONAREVISIONARE, LLCDZL2019-02-21
10810004515786CMF VISIONAREVISIONARE, LLCDZL2019-02-21