FDA.reportPublic FDA data

Enztec ORD - Locking - Bridgeback - Large AO

Primary DI
09421028113274
Brand
Enztec ORD - Locking - Bridgeback - Large AO
Company
ENZTEC LIMITED
Model
4250-7095
Catalog number
4250-7095
Device description
A surgical instrument connected to an active device intended to be used during an orthopaedic surgical procedure
Published
2022-03-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/AttachmentGeneral, Plastic Surgery1
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09421028113274Direct MarkingGS10
00810933031107PrimaryGS10
09421028111065PrimaryGS10
09421028111508PrimaryGS10
09421028111577PrimaryGS10
09421028111584PrimaryGS10
09421028111591PrimaryGS10
09421028111607PrimaryGS10
09421028112598PrimaryGS10
09421028112604PrimaryGS10
09421028112611PrimaryGS10
09421028118286PrimaryGS10
09421028118293PrimaryGS10
09421028118309PrimaryGS10
09421038411742PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
09421028113274094210281132749421028113274
00810933031107008109330311078109330311070810933031107
09421028111065094210281110659421028111065
09421028111508094210281115089421028111508
09421028111577094210281115779421028111577
09421028111584094210281115849421028111584
09421028111591094210281115919421028111591
09421028111607094210281116079421028111607
09421028112598094210281125989421028112598
09421028112604094210281126049421028112604
09421028112611094210281126119421028112611
09421028118286094210281182869421028118286
09421028118293094210281182939421028118293
09421028118309094210281183099421028118309
09421038411742094210384117429421038411742

GMDN Terms#

Term, Definition table
TermDefinition
Surgical power tool adaptorA connecting device designed as a mechanical coupling to join and lock together a distal tool to the surgical power tool to provide the power when these are incompatible and are of a different manufacture/industry standard. It is typically made from high-grade stainless steel and/or synthetic material and is available in a variety of shapes and sizes. This device may be cannulated to allow the use of a guidewire. There are various types such as a Hudson adaptor, Trinkle adaptor, Zimmer adaptor. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
781-345-9001customer-service@conformis.com

Regulatory Flags#

DUNS number
592616445
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
09421038412220Enztec XR Trinket M8X1.0-014252-24494252-24492026-03-13
09421038412145Cup reamer handle, offset, Z/H, locking9209-13019209-13012026-03-09
09421038412152Offset coupling, Z/H9209-13069209-13062026-03-09
09421038412169Offset drive train, locking9209-13039209-13032026-03-09
09421038412176Short Offset Cover – United9209-13079209-13072026-03-09
09421038412183Handle – United9209-13059209-13052026-03-09
09421038412299Cup reamer handle, offset, AO, locking9209-13119209-13112026-03-09
09421038412305Offset coupling, AO9209-13139209-13132026-03-09
09421038412312Cup reamer handle, offset, AO, open9209-13129209-13122026-03-09
09421038412329Offset drive train, open9209-13049209-13042026-03-09
09421038412671Cup reamer handle, offset, Z/H, open9209-13029209-13022026-03-09
09421038411865Enztec Modular OCI X4251-31014251-31012026-02-27
09421038411889Adj Dist Fem Alignment Guide – Cartilage4240-77004240-77002026-02-27
09421038411896Adj Dist Fem Alignment Guide – Paddle4240-77014240-77012026-02-27
09421038411902Sagittal Alignment Connector - Pivot4240-77054240-77052026-02-27
09421038411919Sagittal Alignment Connector - Pivot with Fan4240-77064240-77062026-02-27
09421038411926Dist Fem Cut Block Connector – 8mm4240-77104240-77102026-02-27
09421038411933Dist Fem Cut Block Connector – 9mm4240-77114240-77112026-02-27
09421038411940Dist Fem Cut Block Connector – 10mm4240-77124240-77122026-02-27
09421038411957Dist Fem Cut Block Slot Connector – 8mm4240-77254240-77252026-02-27

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