FDA.reportPublic FDA data

S2

Primary DI
04546540395498
Brand
S2
Company
Stryker Trauma GmbH
Model
1722-1134S
Catalog number
1722-1134S
Device description
Tibial Nail
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
K032579000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K032579000S2 NAIL SYSTEMHowmedica Osteonics Corp.2003-08-29HSB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04546540395498PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04546540395498045465403954984546540395498

GMDN Terms#

Term, Definition table
TermDefinition
Tibia nail, sterileA sterile rod made of metal or other material which, when inserted into the intramedullary canal of the tibia, acts to immobilize by holding the ends of a fractured bone in position to promote healing. The device may also be used to support the bone in the presence of a pathological condition, or for knee arthrodesis. The device may be a locked or unlocked model, and possess components to assist fixation of more proximal or distal conditions. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length345Millimeter

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
04546540394972S21722-0001S1722-0001S2015-09-24
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
18059015376838Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
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