FDA.reportPublic FDA data

S2

Primary DI
04546540394972
Brand
S2
Company
Stryker Trauma GmbH
Model
1722-0001S
Catalog number
1722-0001S
Device description
Compression screw
Published
2015-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HSBROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSBRod, Fixation, Intramedullary And AccessoriesOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K021026000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K021026000S2 FEMORAL NAILHowmedica Osteonics Corp.2002-04-25HSB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04546540394972PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04546540394972045465403949724546540394972

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

Regulatory Flags#

DUNS number
330211587
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04546540394989S21722-0002S1722-0002S2015-09-24
04546540394996S21722-0003S1722-0003S2015-09-24
04546540395009S21722-0005S1722-0005S2015-09-24
04546540395016S21722-0010S1722-0010S2015-09-24
04546540395023S21722-0015S1722-0015S2015-09-24
04546540401168S21745-0003S1745-0003S2015-09-24
04546540399458S21795-5001S1795-5001S2015-09-24
04546540395160S21722-0924S1722-0924S2015-09-24
04546540395177S21722-0925S1722-0925S2015-09-24
04546540395184S21722-0927S1722-0927S2015-09-24
04546540395191S21722-0928S1722-0928S2015-09-24
04546540395207S21722-0930S1722-0930S2015-09-24
04546540395214S21722-0931S1722-0931S2015-09-24
04546540395221S21722-0933S1722-0933S2015-09-24
04546540395238S21722-0934S1722-0934S2015-09-24
04546540395245S21722-0936S1722-0936S2015-09-24
04546540395252S21722-0937S1722-0937S2015-09-24
04546540395269S21722-0939S1722-0939S2015-09-24
04546540395276S21722-0940S1722-0940S2015-09-24
04546540395283S21722-0942S1722-0942S2015-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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18059015376845Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
18059015376852Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
18059015376869Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
18059015376876Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
18059015376883Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
18059015376890Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
18059015376906Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
18059015376913Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
18059015376920Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
18059015376937Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
18059015376944Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
18059015376951Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
18059015376968Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
18059015376975Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
18059015376982Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
18059015376999Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
18059015377002Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
18059015377019Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
18059015377026Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
18059015377033Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
18059015377040Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
18059015377057Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
18059015377064Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
18059015377071Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
18059015377088Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
18059015377095Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
18059015377101Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
18059015377118Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
18059015377125Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23