FDA.reportPublic FDA data

IPP-ON

Primary DI
10381780045908
Brand
IPP-ON
Company
NEWDEAL
Model
230002SND
Catalog number
230002SND
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
10381780045908PrimaryGS10
M248230002SND1SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178004590810381780045908

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
10381780045687K-WIRE115071ND115071ND2017-10-09
10381780045731K-WIRE115110ND115110ND2017-10-09
10381780045755K-WIRE115111ND115111ND2017-10-09
10381780045786K-WIRE115170ND115170ND2017-10-09
10381780045809K-WIRE115171ND115171ND2017-10-09
10381780045847K-WIRE115316ND115316ND2017-10-09
10381780045854K-WIRE115416ND115416ND2017-10-09
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776405960MillenniumAvalign Technologies, Inc.HTY2026-07-28
00190776403928MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776403935MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436025MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436032MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436049MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436056MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436063MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436070MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436087MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436094MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436100MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436117MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436124MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436131MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436148MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776403775MillenniumAvalign Technologies, Inc.HTY2026-07-21
00190776403850MillenniumAvalign Technologies, Inc.HTY2026-07-21
09353903030225OCTOPi Suture Anchor SystemFIELD ORTHOPAEDICS PTY LTDHTY2026-07-15
09353903030317OCTOPi Suture Anchor SystemFIELD ORTHOPAEDICS PTY LTDHTY2026-07-15
09353903030324OCTOPi Suture Anchor SystemFIELD ORTHOPAEDICS PTY LTDHTY2026-07-15
05055662968545OrthoSolutions 'System26' Bone ScrewsORTHO SOLUTIONS HOLDINGS LIMITEDHTY2026-06-24
09353903030218Griplasty SystemFIELD ORTHOPAEDICS PTY LTDHTY2026-06-24
07630894830822APTUSMedartis AGHTY2026-06-01
07630894830839APTUSMedartis AGHTY2026-06-01
07630894830884APTUSMedartis AGHTY2026-06-01
07630894830891APTUSMedartis AGHTY2026-06-01
10888867544571Arthrex®ARTHREX, INC.HTY2026-03-13
07649990202419Drill S-PI-A1.6 extra shortSurgical Fusion Technologies GmbHHTY2026-01-18
07649990202174Geomax Reamer S-PI-A1.6Surgical Fusion Technologies GmbHHTY2025-10-01