FDA.reportPublic FDA data

NA

Primary DI
10886982295354
Brand
NA
Company
Synthes GmbH
Model
04.045.384S
Catalog number
04045384S
Device description
LOW PROF LCKNG SCREW F/IM NAIL Ø 5.0MM / L 84MM/ XL25/ STER
Published
2021-05-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HSBROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
HWCScrew, fixation, bone
JDSNAIL, FIXATION, BONE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSBRod, Fixation, Intramedullary And AccessoriesOrthopedic2
HWCScrew, Fixation, BoneOrthopedic2
JDSNail, Fixation, BoneOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K201336000
K201346000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K201336000DePuy Synthes Tibial Nail Advanced, Depuy Synthes Locking Screws Medullary Nails, 4.0 and 5.0mmSynthes (USA) Products, LLC2020-09-03JDS
K201346000DePuy Synthes Retrograde Femoral Nail Advanced System, DePuy Synthes Locking Screws for Medullary Nails, 5.0 mmSynthes (USA) Products, LLC2020-09-23HSB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10886982295354PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088698229535410886982295354

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw, non-bioabsorbable, sterileA small, sterile, threaded rod with a slotted head typically used for internal orthopaedic fracture fixation by being screwed into bone to hold plates or nails to bone or to provide direct interfragmentary stabilization of bone, or it may fasten soft tissue to bone; it is made of a material that cannot be chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). There are a number of kinds available: cortical, cancellous, malleolar, scaphoid, partially-threaded and fully-threaded, self-tapping, and cannulated. A "lag screw" can be any of these used to obtain compression across bone fragments.

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
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10886982113078NA04.130.260S04130260S2016-03-15
10886982077868NA03.311.010033110102015-09-14
10886982077875NA03.311.011033110112015-09-14
10886982077882NA03.311.012033110122015-09-14
10886982077899NA03.311.013033110132015-09-14
10886982078131NA03.311.058033110582015-09-14
10886982078148NA03.311.059033110592015-09-14
10886982078155NA03.311.060033110602015-09-14
10886982078186NA03.311.062033110622015-09-14
10886982078193NA03.311.070033110702015-09-14
10886982078209NA03.311.071033110712015-09-14
10886982078247NA03.311.090033110902015-09-14
10886982078254NA03.311.091033110912015-09-14
10886982078261NA03.311.092033110922015-09-14
10886982078438NA03.311.201033112012015-09-14
10886982078445NA03.311.202033112022015-09-14
10886982078452NA03.311.203033112032015-09-14
10886982078469NA03.311.204033112042015-09-14
10886982078476NA03.311.205033112052015-09-14
10886982078520NA03.311.220033112202015-09-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00885556904879EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556904923EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906163EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906170EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906187EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906194EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906200EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906217EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906224EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906231EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906248EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906255EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906262EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906279EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906286EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906293EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906309EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906316EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906323EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556901946EVOSSmith & Nephew, Inc.HWC2026-06-24
00193982586393CAPTIVATEGLOBUS MEDICAL, INC.HWC2026-06-10
00193982586416CAPTIVATEGLOBUS MEDICAL, INC.HWC2026-06-10
00193982586430CAPTIVATEGLOBUS MEDICAL, INC.HWC2026-06-10
00193982586454CAPTIVATEGLOBUS MEDICAL, INC.HWC2026-06-10
00193982586478CAPTIVATEGLOBUS MEDICAL, INC.HWC2026-06-10
00193982586690CAPTIVATEGLOBUS MEDICAL, INC.HWC2026-06-10
00193982586706CAPTIVATEGLOBUS MEDICAL, INC.HWC2026-06-10
00193982586713CAPTIVATEGLOBUS MEDICAL, INC.HWC2026-06-10
00193982586720CAPTIVATEGLOBUS MEDICAL, INC.HWC2026-06-10
00193982586737CAPTIVATEGLOBUS MEDICAL, INC.HWC2026-06-10