FDA.reportPublic FDA data

Percutaneous Compression Plate (PC.C.P)

Primary DI
18032568866049
Brand
Percutaneous Compression Plate (PC.C.P)
Company
ORTHOFIX SRL
Model
1
Catalog number
182100
Device description
GOTFRIED PC.C.P. NECK SCREW - 100 MM
Published
2016-09-16
Public version status
Update
Distribution status
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
JDODevice, Fixation, Proximal Femoral, Implant

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDODevice, Fixation, Proximal Femoral, ImplantOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K983814000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K983814000GOTFRIED PERCUTANEOUS COMPRESSION PLATING SYSTEMEfratgo, Ltd. HI Tech Bio-Surgical1999-01-14JDO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18032568866049PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1803256886604918032568866049

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw, non-bioabsorbable, non-sterileA small, non-sterile, threaded rod with a slotted head typically used for internal orthopaedic fracture fixation by being screwed into bone to hold plates or nails to bone or to provide direct interfragmentary stabilization of bone, or it may fasten soft tissue to bone; it is made of a material that cannot be chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). Screws available are: cortical, cancellous, malleolar, scaphoid, partially-threaded and fully-threaded, self-tapping, and cannulated. A "lag screw" can be any of these used to obtain compression. This device must be sterilized prior to use.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length100Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+039456719000info@orthofix.it

Regulatory Flags#

DUNS number
438793622
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
18032568033229Surgical Instruments1136202026-07-23
18032568033236Surgical Instruments1136212026-07-23
18032568036008WRIST FIXATION SYSTEMS1360082026-07-23
18059015376838Fitbone Transport and Lengthening System199-600038172026-07-23
18059015376845Fitbone Transport and Lengthening System199-600038182026-07-23
18059015376852Fitbone Transport and Lengthening System199-600038192026-07-23
18059015376869Fitbone Transport and Lengthening System199-600038202026-07-23
18059015376876Fitbone Transport and Lengthening System199-600038212026-07-23
18059015376883Fitbone Transport and Lengthening System199-600038222026-07-23
18059015376890Fitbone Transport and Lengthening System199-600038232026-07-23
18059015376906Fitbone Transport and Lengthening System199-600038242026-07-23
18059015376913Fitbone Transport and Lengthening System199-600038252026-07-23
18059015376920Fitbone Transport and Lengthening System199-600038262026-07-23
18059015376937Fitbone Transport and Lengthening System199-600038272026-07-23
18059015376944Fitbone Transport and Lengthening System199-600038282026-07-23
18059015376951Fitbone Transport and Lengthening System199-600038292026-07-23
18059015376968Fitbone Transport and Lengthening System199-600038302026-07-23
18059015376975Fitbone Transport and Lengthening System199-600038312026-07-23
18059015376982Fitbone Transport and Lengthening System199-600038322026-07-23
18059015376999Fitbone Transport and Lengthening System199-600038332026-07-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10886982174994DHSSynthes GmbHJDO2015-09-14
10886982175007DHSSynthes GmbHJDO2015-09-14
10886982175014DHSSynthes GmbHJDO2015-09-14
10886982175021DHSSynthes GmbHJDO2015-09-14
10886982175038DHSSynthes GmbHJDO2015-09-14
10886982175045DHSSynthes GmbHJDO2015-09-14
10886982175052DHSSynthes GmbHJDO2015-09-14
10886982175069DHSSynthes GmbHJDO2015-09-14
10886982175076DHSSynthes GmbHJDO2015-09-14
10886982175083DHSSynthes GmbHJDO2015-09-14
10886982175090DHSSynthes GmbHJDO2015-09-14
10886982175106DHSSynthes GmbHJDO2015-09-14
10886982175113DHSSynthes GmbHJDO2015-09-14
10886982175120DHSSynthes GmbHJDO2015-09-14
10886982175137DHSSynthes GmbHJDO2015-09-14
10886982175144DHSSynthes GmbHJDO2015-09-14
10886982175151DHSSynthes GmbHJDO2015-09-14
10886982175168DHSSynthes GmbHJDO2015-09-14
10886982175175DHSSynthes GmbHJDO2015-09-14
10886982175182DHSSynthes GmbHJDO2015-09-14
10886982175212DHSSynthes GmbHJDO2015-09-14
10886982175229DHSSynthes GmbHJDO2015-09-14
10886982175236DHSSynthes GmbHJDO2015-09-14
10886982175243DHSSynthes GmbHJDO2015-09-14
10886982175250DHSSynthes GmbHJDO2015-09-14
10886982175267DHSSynthes GmbHJDO2015-09-14
10886982175274DHSSynthes GmbHJDO2015-09-14
10886982175281DHSSynthes GmbHJDO2015-09-14
10886982175298DHSSynthes GmbHJDO2015-09-14
10886982175304DHSSynthes GmbHJDO2015-09-14