FDA.reportPublic FDA data

IPP-ON

Primary DI
10381780045892
Brand
IPP-ON
Company
NEWDEAL
Model
230001SND
Catalog number
230001SND
Device description
The Newdeal Interphalangeal implant is designed to respect anatomical flexion to achieve fixation of interphalangeal arthrodesis of the lesser toes in case of rigid or semi-rigid hammertoe deformity, revision of failed arthroplasty or arthrodesis, and shortening due to length excess of the second toe. The implant configuration is available in two different sizes and is manufactured from Stainless Steel. It is delivered sterile.
Published
2017-10-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HTYPIN, FIXATION, SMOOTH

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTYPin, Fixation, SmoothOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K103623000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K103623000NEWDEAL INTERPHALANGEAL IMPLANTNewdeal Sas2012-03-20HTY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780045892PrimaryGS10
M248230001SND1SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178004589210381780045892

GMDN Terms#

Term, Definition table
TermDefinition
Phalangeal joint arthrodesis implantA small, non-bioabsorbable, implantable device of fixed-length designed to be inserted within a phalangeal joint (i.e., not a plate) in the finger and/or toe (i.e., interphalangeal or phalangeal/metacarpal/metatarsal) to fuse the joint (arthrodesis), typically to manage arthritis or deformities (e.g., hammer toe), or for arthroplasty revision; it is not intended for carpal, tarsal or ankle implantation. It is typically made of metal and can be of several small designs (e.g., rod with barbs at each end, X-shaped, single or dual screw), however it is not intended to be fixed into bone with bone screws (i.e., not an intramedullary nail).

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in dry place.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)654-2873custsvcnj@integralife.com

Regulatory Flags#

DUNS number
536935331
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10381780041771QWIX®119932ND2017-05-26
10381780042099Hallu®-FIX129930ND2017-05-26
10381780042136Hallu®-FIX129935ND2017-05-26
10381780042266ADVANSYS®169101ND2017-05-26
10381780042273ADVANSYS®169102ND2017-05-26
10381780042280ADVANSYS®169104ND2017-05-26
10381780042327ADVANSYS®188201ND2017-05-26
10381780042334ADVANSYS®188202ND2017-05-26
10381780042419IPP-ON®239000ND2017-05-26
10381780042426IPP-ON®239001ND2017-05-26
10381780042778PANTA®519920ND2017-05-26
10381780042822SURFIX®SET000ND2017-05-26
10381780042839SURFIX®SET100ND2017-05-26
10381780042846SURFIX®SET101ND2017-05-26
10381780052005SURFIX®219765ND2017-05-26
10381780052036SURFIX®MA003ND2017-05-26
10381780052166METIS®119601ND2017-05-26
10381780052999PANTA®519130ND2017-05-31
10381780126539TIBIAXYS®159985ND2017-05-26
10381780044574PANTA XL510004ND510004ND2017-10-09

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Primary DI, Brand, Company table
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07649990202211Geomax Reamer S-PI-A2.3Surgical Fusion Technologies GmbHHTY2025-10-01
07649990202372Geomax Reamer S-PI-A3.0Surgical Fusion Technologies GmbHHTY2025-10-01
07649990202389Handle SSurgical Fusion Technologies GmbHHTY2025-10-01
07649990202396Geomax Reamer SetSurgical Fusion Technologies GmbHHTY2025-10-01
07630037863977APTUSMedartis AGHTY2025-07-31
07630037863984APTUSMedartis AGHTY2025-07-31
07630037864011APTUSMedartis AGHTY2025-04-08
07630037864264APTUSMedartis AGHTY2025-04-08
07613327084191STEINMANNStryker GmbHHTY2025-01-09
09353903030003Griplasty SystemFIELD ORTHOPAEDICS PTY LTDHTY2024-09-19
07649990202075SupraFuser GeneratorSurgical Fusion Technologies GmbHHTY2024-04-12
07649990202228SF Push-in Anchor 1.6Surgical Fusion Technologies GmbHHTY2024-04-12
07649990202235SF Push-in Anchor 3.0Surgical Fusion Technologies GmbHHTY2024-04-12
07649990202259Stopper S-PI-A1.6Surgical Fusion Technologies GmbHHTY2024-04-12
07649990202266Stopper S-PI-A2.3Surgical Fusion Technologies GmbHHTY2024-04-12
07649990202273Stopper S-PI-A3.0Surgical Fusion Technologies GmbHHTY2024-04-12
07649990202297Guide S-PI / W5.0Surgical Fusion Technologies GmbHHTY2024-04-12
07649990202303Sonotrode S-PISurgical Fusion Technologies GmbHHTY2024-04-12
07649990202310Drill S-PI-A1.6Surgical Fusion Technologies GmbHHTY2024-04-12
07649990202327Drill S-PI-A2.3Surgical Fusion Technologies GmbHHTY2024-04-12
07649990202334Drill S-PI-A3.0Surgical Fusion Technologies GmbHHTY2024-04-12
07649990202365Tray SF Push-in Anchor PortfolioSurgical Fusion Technologies GmbHHTY2024-04-12
07630037863854APTUSMedartis AGHTY2024-03-22
07630037863915APTUSMedartis AGHTY2024-03-22