FDA.reportPublic FDA data

NA

Primary DI
07613327459005
Brand
NA
Company
Stryker Leibinger GmbH & Co. KG
Model
92-10678
Catalog number
92-10678
Device description
SIZER FOR SURGEON ID MAND RECON PLATE
Published
2019-07-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
HWTTEMPLATE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWTTemplateOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613327459005PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327459005076133274590057613327459005

GMDN Terms#

Term, Definition table
TermDefinition
Surgical implant template, single-useA device designed to determine the appropriate size and placement of a non-dental implant for a patient prior to or during implantation surgery. It is typically available as a graduated set or an individual plate (e.g., a translucent plastic sheet or a cut metal shape) with patterns/sizes corresponding to the size of the implant to be used to aid the surgeon in final selection of implant size, placement, and/or adaption. It is used for, e.g., total- or partial-joint prostheses, bone fracture fixation implants (plates, nails, including skull plate implants) or other types of surgical implants. This is a single-use device.

Device Sizes#

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

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
316153956
Device count
1
Premarket exempt
true
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
07613154731800NA92-1592392-159232017-01-11
07613154732685NA92-1592192-159212017-01-11
04546540256805NA62-0053462-005342016-10-19
04546540356529NA60-1605060-160502016-08-24
04546540356628NA62-0030262-003022016-12-08
07613154185443NA62-0044162-004412016-12-08
07613252313069DELTA70-9200970-920092015-09-24
07613252444220DELTA70-9200670-920062015-09-24
07613252444244DELTA70-9200370-920032015-09-24
07613327090123NA62-2014962-201492016-10-19
07613327090192NA62-2013962-201392016-10-19
07613327123340Delta70-9205670-920562015-09-24
07613327123364Delta70-9205570-920552015-09-24
04546540366788NA62-2052062-205202016-10-19
04546540391391NA62-0020862-002082016-12-08
07613252727002DELTA70-9204770-920472015-09-24
07613252286578FLUOROMAP6006-600-0006006-600-0002025-01-28
07613327542202N/A81-8007081-800702023-05-11
07613327542219N/A6003-700-3006003-700-3002023-05-11
07613327542363N/A6003-710-3006003-710-3002023-05-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04260056885877InterSpace® Hip Mold Trial Short StemOSARTIS GmbHHWT2026-10-29
04260056885891InterSpace® Hip Mold Trial Short StemOSARTIS GmbHHWT2026-10-29
04260056885914InterSpace® Hip Mold Trial Short StemOSARTIS GmbHHWT2026-10-29
04260056885938InterSpace® Hip Mold Trial Long StemOSARTIS GmbHHWT2026-10-29
04260056885952InterSpace® Hip Mold Trial Long StemOSARTIS GmbHHWT2026-10-29
04260056885976InterSpace® Hip Mold Trial Long StemOSARTIS GmbHHWT2026-10-29
04260056885990InterSpace® Hip Mold Trial Head 42 mmOSARTIS GmbHHWT2026-10-29
04260056886010InterSpace® Hip Mold Trial Head 48 mmOSARTIS GmbHHWT2026-10-29
04260056886034InterSpace® Hip Mold Trial Head 52 mmOSARTIS GmbHHWT2026-10-29
04260056886058InterSpace® Hip Mold Trial Head 56 mmOSARTIS GmbHHWT2026-10-29
04260056886072InterSpace® Hip Mold Trial Head 60 mmOSARTIS GmbHHWT2026-10-29
04260056886096InterSpace® Knee Mold Trial Femoral Component XSOSARTIS GmbHHWT2026-10-29
04260056886119InterSpace® Knee Mold Trial Femoral Component SOSARTIS GmbHHWT2026-10-29
04260056886133InterSpace® Knee Mold Trial Femoral Component MOSARTIS GmbHHWT2026-10-29
04260056886157InterSpace® Knee Mold Trial Femoral Component LOSARTIS GmbHHWT2026-10-29
04260056886171InterSpace® Knee Mold Trial Femoral Component XLOSARTIS GmbHHWT2026-10-29
04260056886195InterSpace® Knee Mold Trial Tibial Component XSOSARTIS GmbHHWT2026-10-29
04260056886218InterSpace® Knee Mold Trial Tibial Component SOSARTIS GmbHHWT2026-10-29
04260056886232InterSpace® Knee Mold Trial Tibial Component MOSARTIS GmbHHWT2026-10-29
04260056886256InterSpace® Knee Mold Trial Tibial Component LOSARTIS GmbHHWT2026-10-29
04260056886270InterSpace® Knee Mold Trial Tibial Component XLOSARTIS GmbHHWT2026-10-29
04260056886287InterSpace® Knee Mold Trial Tibial StemOSARTIS GmbHHWT2026-10-29
04260056886416InterSpace® Knee Mold Trial Tibial InsertOSARTIS GmbHHWT2026-10-29
04260056886423InterSpace® Knee Mold Trial Tibial Stemmed InsertOSARTIS GmbHHWT2026-10-29
00889024702493OsseoFitZimmer, Inc.HWT2026-10-27
00889024702509OsseoFitZimmer, Inc.HWT2026-10-27
00889024702516OsseoFitZimmer, Inc.HWT2026-10-27
00889024702561OsseoFitZimmer, Inc.HWT2026-10-27
00889024702578OsseoFitZimmer, Inc.HWT2026-10-27
00889024702585OsseoFitZimmer, Inc.HWT2026-10-27