FDA.reportPublic FDA data

TOEGRIP® Classic

Primary DI
03701091000302
Brand
TOEGRIP® Classic
Company
ADSM
Model
TGXL20
Catalog number
TGXL20
Device description
Interphalangeal device
Published
2020-12-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
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
K133477000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K133477000TOEGRIP, IMPLANT FOR PROXIMAL INTER-PHALANGEAL ARTHRODESISSynchro Medical2014-02-10HTY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03701091000302PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03701091000302037010910003023701091000302

GMDN Terms#

Term, Definition table
TermDefinition
Interphalangeal joint arthrodesis implantA sterile implantable device designed to be inserted across a toe or finger interphalangeal joint, into the contiguous phalanges, to fuse the joint (arthrodesis), typically to correct joints damaged by traumatic, degenerative or rheumatoid arthritis, or other deformities (e.g., hammer toe), or for arthroplasty revision. It is made of metal [(e.g., stainless steel, nickel-titanium alloy (Nitinol)]) and can be of several geometric shapes (e.g., a small rod with barbs at each end, or X-shaped); devices associated with implantation may be included.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Angle20degree
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+33428710310office@synchromedical.com
+1 409-658-1017info@iotiot.com

Regulatory Flags#

DUNS number
266749350
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03701091006250PURIST 6813009B6813009B2023-04-24
03701091006267PURIST 6813040B6813040B2023-04-24
03701091006274PURIST 6813049B6813049B2023-04-24
03701091006281PURIST 6883314B6883314B2023-04-24
03701091006298PURIST 6883360B6883360B2023-04-24
03701091006304PURIST6813037B6813037B2023-04-24
03701091006311PURIST6813123B6813123B2023-04-24
03701091006328PURIST 6813035B6813035B2023-04-24
03701091006335PURIST 6813041B6813041B2023-04-24
03701091006342PURIST 6813048B6813048B2023-04-24
03701091005369PURIST 688331468833142022-11-28
03701091005376PURIST 688336068833602022-11-28
03701091005383PURIST 681311768131172022-11-28
03701091005390PURIST 681311868131182022-11-28
03701091005406PURIST 681311968131192022-11-28
03701091005413PURIST681311468131142022-11-28
03701091005420PURIST 681312068131202022-11-28
03701091005437PURIST 681311668131162022-11-28
03701091005444PURIST 681300268130022022-11-28
03701091005451PURIST 681300968130092022-11-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
07649990202211Geomax Reamer S-PI-A2.3Surgical Fusion Technologies GmbHHTY2025-10-01