FDA.reportPublic FDA data

INSTRUMENT

Primary DI
07613327306750
Brand
INSTRUMENT
Company
Howmedica Osteonics Corp.
Model
I-K2767KF01
Catalog number
I-K2767KF01
Device description
SPECIALTY RESECTION GONIOMETER - SHORT
Published
2018-09-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613327306750PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327306750076133273067507613327306750

GMDN Terms#

Term, Definition table
TermDefinition
Manual goniometerA non-powered, manually-operated measuring device, graduated in degrees (e.g., from 0 to 360 degrees), designed to be used in a clinical setting to measure the range of motion of the limb of a patient by measuring the angle of movement achieved at the joint. It is typically used by rheumatologists, physiotherapists, orthopaedists and general practitioners to evaluate joint movement (e.g., ankle, finger, knee, shoulder or spine) before and after a medical/surgical intervention. It may be made of plastic or stainless steel and is available in various designs (e.g., protractor-like with pivoting arms, dial-like with twin rotating dials). This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Lumen/Inner Diameter0.3125Inch

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
058311945
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327128420Simplex6197-9-0016197-9-0012017-06-19
07613327128437Simplex6188-1-0016188-1-0012015-09-24
07613327128444Simplex6191-1-0016191-1-0012015-09-24
07613327128451Simplex6192-1-0016192-1-0012017-06-19
07613327181531INSTRUMENT0901-1-0000901-1-0002016-09-24
07613327020786Secur-Fit6054-0509S6054-0509S2015-09-24
07613327020793Secur-Fit6054-0511S6054-0511S2015-09-24
07613327020809Secur-Fit6054-0610S6054-0610S2015-09-24
07613327020816Secur-Fit6054-0612S6054-0612S2015-09-24
07613327020823Secur-Fit6054-0812S6054-0812S2015-09-24
07613327020830Secur-Fit6054-0713S6054-0713S2015-09-24
07613327020847Secur-Fit6054-0711S6054-0711S2015-09-24
07613327020854Secur-Fit6054-0814S6054-0814S2015-09-24
07613327020861Secur-Fit6054-0913S6054-0913S2015-09-24
07613327020878Secur-Fit6054-1014S6054-1014S2015-09-24
07613327020885Secur-Fit6054-1016S6054-1016S2015-09-24
07613327020892Secur-Fit6054-0915S6054-0915S2015-09-24
07613327020908Secur-Fit6054-1115S6054-1115S2015-09-24
07613327020915Secur-Fit6054-1117S6054-1117S2015-09-24
07613327020922Secur-Fit6054-1216S6054-1216S2015-09-24

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