FDA.reportPublic FDA data

NA

Primary DI
07612334119063
Brand
NA
Company
SYNTHES (U.S.A.) LP
Model
03.028.012
Catalog number
03028012
Device description
CANN SCREWDRIVER BLADE FOR QUICK INSERTION SCREWS W/AO QC
Published
2019-10-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWCScrew, fixation, bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWCScrew, Fixation, BoneOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K180541000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180541000DePuy Synthes 2.0 mm Quick Insertion ScrewsSynthes USA Products, LLC2018-11-21HWC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07612334119063Direct MarkingGS10
10886982273000PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07612334119063076123341190637612334119063
1088698227300010886982273000

GMDN Terms#

Term, Definition table
TermDefinition
Screwing power tool attachmentA device intended to connect to a surgical power tool system motor [it is locked and held in a collet or quick coupling and not simply gripped in a drill chuck (Jacobs chuck)] to convert the non-dedicated mechanical energy provided by the motor to a dedicated mechanical motion to perform a powered screw insertion function when an appropriate screwdriver bit is inserted. It may include integral design features, e.g., have an angled head or have an extended body length to better suit a particular activity. It is typically made of high-grade stainless steel and synthetic materials. The device may be of the micro or macro design. This is a reusable device.

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
832637081
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10886982249210NA60.550.040605500402017-02-20
10886982239884NA530.4125304122016-12-31
10886982192172NA329.7223297222017-02-20
10886982192295LC-DCP329.9183299182017-02-20
10886982201461NA398.56398562017-02-20
10886982201478NA398.58398582017-02-20
10705034718040NA03.620.219036202192018-10-29
10705034767802VentroFix304.8323048322016-12-31
10705034775418NA389.2963892962016-12-31
10705034775425NA389.2973892972016-12-31
10705034775432NA389.2983892982016-12-31
10705034775449NA389.2993892992016-12-31
10705034798455NA690.0386900382016-12-31
10887587039893NA338.7613387612016-12-31
10886982338778MAXFRAME1100022-011100022012024-02-05
10886982338570MAXFRAME1100011-011100011012022-04-26
10886982338587MAXFRAME1100010-011100010012022-04-26
10886982338594MAXFRAME1100012-011100012012022-04-26
10886982338600MAXFRAME1100007-011100007012022-04-26
10886982237217NA510.1615101612019-02-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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07901125620759Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-08-27
07901125620773Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-08-27
07901125620780Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-08-27
07901125620797Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-08-27
07901125620803Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-08-27
07901125620810Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-08-27
07901125620827Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-08-27
07901125620834Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-08-27
07901125620841Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-08-27
07901125620858Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-08-27
07901125620865Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-08-27
07901125620872Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-08-27
07901125620889Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-08-27
07901125620896Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-08-27
07901125620902Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-08-27
07901125620919Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-08-27
07901125620926Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-08-27
07901125620933Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-08-27
07901125620940Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-08-27
07901125620957Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-08-27
07901125620964Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-08-27
07901125620971Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-08-27
07901125620988Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-08-27
07901125620537Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-08-26
07901125620544Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-08-26
07901125620551Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-08-26
07901125620568Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-08-26
07901125620575Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-08-26
07901125620711Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-08-26