FDA.reportPublic FDA data

NA

Primary DI
34546540356483
Brand
NA
Company
Stryker Leibinger GmbH & Co. KG
Model
56-00400
Catalog number
56-00400
Device description
BICONCAVE WASHERS
Published
2015-06-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Single use
true

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
K980364000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K980364000HOWMEDICA AND HOWMEDICA LEIBINGER BONE SCREW WASHERSHowmedica Corp.1998-04-29HWC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
34546540356483PrimaryGS10
04546540356482Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3454654035648334546540356483
04546540356482045465403564824546540356482

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone washerA flat thin ring or plate typically used with a nut and bolt/screw to improve tightness in an orthopaedic fixation assembly. The washer may be made of metal, polymer, or reinforced polymer. This is a single-use device.

Device Sizes#

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

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
316153956
Device count
10
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04546540000057COLORADOAC2000AC20002016-08-24
04546540366634NA62-0019262-001922016-12-08
07613153170549NA60-1672060-167202016-08-24
07613252578208NA78-2102878-210282015-07-03
07613252578215NA78-2002878-200282015-07-03
07613252578222NA78-2002078-200202015-07-03
07613252578239NA78-2102078-210202015-07-03
07613252599647NA78-3002078-300202015-07-03
07613252599654NA78-3002878-300282015-07-03
07613252599661NA78-3102078-310202015-07-03
07613252599678NA78-3102878-310282015-07-03
07613327392715DELTA70-7620170-762012018-06-07
04546540364883NA50-1290050-129002023-02-13
07613327369489AXS62-1217862-121782019-09-11
04546540246332NA60-1010460-101042016-08-24
04546540246356NA60-1010860-101082016-08-24
04546540246387NA60-1011260-101122016-08-24
04546540256805NA62-0053462-005342016-10-19
04546540258991NA62-1740162-174012016-10-19
04546540274175NA64-0010564-001052016-12-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00193982101909ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982101923ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982101947ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982158323ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982158378ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982158422ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982158477ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982158521ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982158576ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982158620ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982158675ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982158729ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982158774ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982158828ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982167615ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982167660ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982167714ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982167769ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982167813ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982167868ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982167912ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982167967ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982168018ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982168063ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982168117ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982175740ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982175795ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14