FDA.reportPublic FDA data

LCP

Primary DI
07611819155121
Brand
LCP
Company
Synthes GmbH
Model
328.042
Catalog number
328042
Device description
CLAMPING FOOT BRD FOR 328.040 LCP® 4.5/5.0MM & LC-DCP® 4.5MM
Published
2016-12-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
FZXGuide, surgical, instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZXGuide, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07611819155121Direct MarkingGS10
10886982191519PrimaryGS10
H6793280420SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07611819155121076118191551217611819155121
1088698219151910886982191519

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant/instrument adaptor, reusableA connecting device designed to join an implant to a surgical instrument or a surgical instrument to another instrument particularly to create an extension or to connect two devices where the interfaces of the devices are not compatible. It is typically made from high-grade stainless steel and/or synthetic material and is available in a variety of sizes and lengths. This device can be used, e.g., during a percutaneous interspinous distraction procedure for the removal of a distraction sleeve. This is a reusable device.

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
486711679
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10886982350435NASD03.100.130SD031001302026-02-11
10886982350442NASD03.100.131SD031001312026-02-11
10886982350459NASD03.100.132SD031001322026-02-11
10886982350466NASD03.100.133SD031001332026-02-11
10886982351579NASD399.190SD3991902026-02-11
10886982351661NASD03.010.001SD030100012026-02-11
10886982351678NASD03.010.002SD030100022026-02-11
10886982361288NASD03.405.001SD034050012026-02-11
10886982361295NASD03.100.038SD031000382026-02-11
10887587078502NASD03.501.443SD035014432026-02-11
10887587078571NASD386.902SD3869022026-02-11
10886982351586NASD03.045.001SD030450012026-02-10
10886982351593NASD03.045.003SD030450032026-02-10
10886982362186NASD03.233.016SD032330162026-01-10
10886982362193NASD03.233.017SD032330172026-01-10
10886982362209NASD03.233.018SD032330182026-01-10
10886982362216NASD03.233.019SD032330192026-01-10
10886982361257VOLT60.529.210605292102025-12-16
H9810460002902S0NA04.600.029.02S0460002902S2019-08-20
H9810460002910S0NA04.600.029.10S0460002910S2019-08-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800200200079Drain-TGJSR MEDICAL CO., LTD.FZX2026-03-23
08800200200086Drain-TGJSR MEDICAL CO., LTD.FZX2026-03-23
00889024706965PSN 10MM M/L SHIFT BLOCKZimmer, Inc.FZX2026-03-19
03662663143462MaxAn Anterior Cervical Plate SystemHighridge Medical, LLCFZX2026-03-17
03662663143479MaxAn Anterior Cervical Plate SystemHighridge Medical, LLCFZX2026-03-17
03662663143486MaxAn Anterior Cervical Plate SystemHighridge Medical, LLCFZX2026-03-17
03662663143493MaxAn Anterior Cervical Plate SystemHighridge Medical, LLCFZX2026-03-17
03662663143509MaxAn Anterior Cervical Plate SystemHighridge Medical, LLCFZX2026-03-17
03662663143516MaxAn Anterior Cervical Plate SystemHighridge Medical, LLCFZX2026-03-17
03662663143523MaxAn Anterior Cervical Plate SystemHighridge Medical, LLCFZX2026-03-17
03662663143530MaxAn Anterior Cervical Plate SystemHighridge Medical, LLCFZX2026-03-17
00763000885212n/aMEDTRONIC SOFAMOR DANEK, INC.FZX2026-03-16
00840277133410Innomed, Inc.INNOMED, INC.FZX2026-03-11
10705034578866N/AMedos International SàrlFZX2026-03-05
10705034578873N/AMedos International SàrlFZX2026-03-05
10705034578880N/AMedos International SàrlFZX2026-03-05
10705034578897N/AMedos International SàrlFZX2026-03-05
00841435120402TecometTECOMET INC.FZX2026-02-27
09421038411889Adj Dist Fem Alignment Guide – CartilageENZTEC LIMITEDFZX2026-02-27
09421038411896Adj Dist Fem Alignment Guide – PaddleENZTEC LIMITEDFZX2026-02-27
09421038411902Sagittal Alignment Connector - PivotENZTEC LIMITEDFZX2026-02-27
09421038411919Sagittal Alignment Connector - Pivot with FanENZTEC LIMITEDFZX2026-02-27
09421038411926Dist Fem Cut Block Connector – 8mmENZTEC LIMITEDFZX2026-02-27
09421038411933Dist Fem Cut Block Connector – 9mmENZTEC LIMITEDFZX2026-02-27
09421038411940Dist Fem Cut Block Connector – 10mmENZTEC LIMITEDFZX2026-02-27
09421038411957Dist Fem Cut Block Slot Connector – 8mmENZTEC LIMITEDFZX2026-02-27
09421038411964Dist Fem Cut Block Slot Connector – 9mmENZTEC LIMITEDFZX2026-02-27
09421038411971Dist Fem Cut Block Slot Connector – 10mmENZTEC LIMITEDFZX2026-02-27
09421038411988Dist Fem Cut Block – 1.27mmENZTEC LIMITEDFZX2026-02-27
09421038411995IM Rod – 8mm x 135mmENZTEC LIMITEDFZX2026-02-27