FDA.reportPublic FDA data

NA

Primary DI
10886982218438
Brand
NA
Company
SYNTHES (U.S.A.) LP
Model
437.70
Catalog number
43770
Device description
95 DEG TI CONDYLAR PLATE 7 HOLES/50MM
Published
2015-09-14
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KTWAPPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, SINGLE COMPONENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KTWAppliance, Fixation, Nail/Blade/Plate Combination, Single ComponentOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K914546000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K914546000ANGLED BLADE PLATESynthes (Usa)1991-11-29KTW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10886982218438PrimaryGS10
H679437700SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088698221843810886982218438

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic fixation plate, non-bioabsorbableA non-bioabsorbable, non-customized, firm, implantable sheet intended to stabilize a fractured orthopaedic bone (excluding craniofacial and spinal) to treat a traumatic/pathological fracture, to fuse a joint (arthrodesis) and/or as part of an osteotomy. Typically attached to a bone of a limb, rib, sternum, or pelvis, it is designed to be fixed in place with screws, and may be used in connection with another fixation plate; it does not incorporate a sleeve or blade. Disposable instruments intended to facilitate implantation, or fixation implants (i.e., bone screws), may be packaged with the plate.

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
832637081
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10887587039893NA338.7613387612016-12-31
10886982338778MAXFRAME1100022-011100022012024-02-05
10886982338570MAXFRAME1100011-011100011012022-04-26
10886982338587MAXFRAME1100010-011100010012022-04-26
10886982338594MAXFRAME1100012-011100012012022-04-26
10886982338600MAXFRAME1100007-011100007012022-04-26
10886982237217NA510.1615101612019-02-21
10887587039305NA329.37329372016-12-31
10705034741161NA04.616.135046161352015-09-14
10705034741178NA04.616.140046161402015-09-14
10705034741260NA04.616.185046161852015-09-14
10705034741284NA04.616.195046161952015-09-14
10886982027795NA02.007.000S02007000S2015-09-14
10886982064745NA03.000.066S03000066S2016-06-30
10886982064820NA03.000.079S03000079S2016-06-30
10886982064844NA03.000.082S03000082S2016-06-30
10886982064882NA03.000.097S03000097S2016-06-30
10886982064905NA03.000.100S03000100S2016-06-30
10886982064929NA03.000.104S03000104S2016-06-30
10886982064936NA03.000.106S03000106S2016-06-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10886982218735NASYNTHES (U.S.A.) LPKTW2018-07-18
08809265150206Leforte System Bone PlateJeil Medical CorporationKTW2015-09-24
08809265150213Leforte System Bone PlateJeil Medical CorporationKTW2015-09-24
08809265150220Leforte System Bone PlateJeil Medical CorporationKTW2015-09-24
08809265150237Leforte System Bone PlateJeil Medical CorporationKTW2015-09-24
08809265150244Leforte System Bone PlateJeil Medical CorporationKTW2015-09-24
08809265150251Leforte System Bone PlateJeil Medical CorporationKTW2015-09-24
08809265150268Leforte System Bone PlateJeil Medical CorporationKTW2015-09-24
08809265150275Leforte System Bone PlateJeil Medical CorporationKTW2015-09-24
08809265150282Leforte System Bone PlateJeil Medical CorporationKTW2015-09-24
08809265150299Leforte System Bone PlateJeil Medical CorporationKTW2015-09-24
08809265150305Leforte System Bone PlateJeil Medical CorporationKTW2015-09-24
08809265150312Leforte System Bone PlateJeil Medical CorporationKTW2015-09-24
08809265150329Leforte System Bone PlateJeil Medical CorporationKTW2015-09-24
08809265150336Leforte System Bone PlateJeil Medical CorporationKTW2015-09-24
08809265150510Leforte System Bone PlateJeil Medical CorporationKTW2015-09-24
08809265150527Leforte System Bone PlateJeil Medical CorporationKTW2015-09-24
08809265150534Leforte System Bone PlateJeil Medical CorporationKTW2015-09-24
08809265150541Leforte System Bone PlateJeil Medical CorporationKTW2015-09-24
08809265150572Leforte System Bone PlateJeil Medical CorporationKTW2015-09-24
08809265150589Leforte System Bone PlateJeil Medical CorporationKTW2015-09-24
08809265150596Leforte System Bone PlateJeil Medical CorporationKTW2015-09-24
08809265150602Leforte System Bone PlateJeil Medical CorporationKTW2015-09-24
08809265150671Leforte System Bone PlateJeil Medical CorporationKTW2015-09-24
08809265150688Leforte System Bone PlateJeil Medical CorporationKTW2015-09-24
08809265151203Leforte System Bone PlateJeil Medical CorporationKTW2015-09-24
08809265151210Leforte System Bone PlateJeil Medical CorporationKTW2015-09-24
08809265151227Leforte System Bone PlateJeil Medical CorporationKTW2015-09-24
08809265151234Leforte System Bone PlateJeil Medical CorporationKTW2015-09-24
08809265151241Leforte System Bone PlateJeil Medical CorporationKTW2015-09-24