FDA.reportPublic FDA data

NA

Primary DI
00846832090150
Brand
NA
Company
TORNIER, INC.
Model
ARS743700
Catalog number
ARS743700
Device description
Trephine Adaptor
Published
2022-08-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWKTREPHINE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWKTrephineOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00846832090150PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00846832090150008468320901508468320901500846832090150

GMDN Terms#

Term, Definition table
TermDefinition
Bone trephineAn orthopaedic surgical blade designed to cut and remove circular sections of bone, typically for biopsy or percutaneous bone graft harvesting. It is typically a hollow cylinder with a circular, saw-like serrated working edge. It is an exchangeable device that may be attached to a manually-operated handle or to a powered rotary surgical handpiece. The device is typically made of high-grade stainless steel. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(888)494-7950customerservice@tornier.com

Regulatory Flags#

DUNS number
968990812
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00846832077632PERFORM™ HUMERAL SYSTEMDWR13602020-11-10
00846832077649PERFORM™ HUMERAL SYSTEMDWR13632020-11-10
00846832077656PERFORM™ HUMERAL SYSTEMDWR13662020-11-10
00846832077663PERFORM™ HUMERAL SYSTEMDWR13902020-11-10
00846832077670PERFORM™ HUMERAL SYSTEMDWR13932020-11-10
00846832077687PERFORM™ HUMERAL SYSTEMDWR13962020-11-10
00846832077694PERFORM™ HUMERAL SYSTEMDWR23602020-11-10
00846832077700PERFORM™ HUMERAL SYSTEMDWR23632020-11-10
00846832077717PERFORM™ HUMERAL SYSTEMDWR23662020-11-10
00846832077724PERFORM™ HUMERAL SYSTEMDWR23902020-11-10
00846832077731PERFORM™ HUMERAL SYSTEMDWR23932020-11-10
00846832077748PERFORM™ HUMERAL SYSTEMDWR23962020-11-10
00846832077755PERFORM™ HUMERAL SYSTEMDWR24202020-11-10
00846832077762PERFORM™ HUMERAL SYSTEMDWR24232020-11-10
00846832077779PERFORM™ HUMERAL SYSTEMDWR24262020-11-10
00846832077786PERFORM™ HUMERAL SYSTEMDWR33302020-11-10
00846832077793PERFORM™ HUMERAL SYSTEMDWR33332020-11-10
00846832077809PERFORM™ HUMERAL SYSTEMDWR33362020-11-10
00846832077816PERFORM™ HUMERAL SYSTEMDWR33602020-11-10
00846832077823PERFORM™ HUMERAL SYSTEMDWR33632020-11-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03662663217477Vail OCT Spinal Fixation SystemHighridge Medical, LLCHWK2025-12-17
03662663217484Vail OCT Spinal Fixation SystemHighridge Medical, LLCHWK2025-12-17
03662663217491Vail OCT Spinal Fixation SystemHighridge Medical, LLCHWK2025-12-17
03662663217507Vail OCT Spinal Fixation SystemHighridge Medical, LLCHWK2025-12-17
03662663134392C-THRU Anterior Spinal Spacer SystemHighridge Medical, LLCHWK2025-12-03
03662663136327Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHWK2025-12-03
03662663136334Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHWK2025-12-03
03662663136341Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHWK2025-12-03
03662663136358Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHWK2025-12-03
03662663136365Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHWK2025-12-03
10193489179583MEDLINEMEDLINE INDUSTRIES, INC.HWK2025-07-11
10193489179590MEDLINEMEDLINE INDUSTRIES, INC.HWK2025-07-11
00850055649705INTREPED Extraction KitAuxano Medical LLCHWK2025-01-10
00190776384609MillenniumAvalign Technologies, Inc.HWK2024-08-22
00190776384616MillenniumAvalign Technologies, Inc.HWK2024-08-22
B756STR00107SP1Shukla Trephine S9TREPHINEShukla MedicalHWK2024-08-21
B756STR00108SP1Shukla Trephine S9TREPHINEShukla MedicalHWK2024-08-21
B756STR00109SP1Shukla Trephine S9TREPHINEShukla MedicalHWK2024-08-21
B756STR00110SP1Shukla Trephine S9TREPHINEShukla MedicalHWK2024-08-21
B756STR00111SP0Shukla Trephine S9TREPHINEShukla MedicalHWK2024-08-21
B756STR00112SP1Shukla Trephine S9TREPHINEShukla MedicalHWK2024-08-21
B756STR00113SP1Shukla Trephine S9TREPHINEShukla MedicalHWK2024-08-21
B756STR00114SP1Shukla Trephine S9TREPHINEShukla MedicalHWK2024-08-21
B756STR00115SP1Shukla Trephine S9TREPHINEShukla MedicalHWK2024-08-21
B756STR00116SP0Shukla Trephine S9TREPHINEShukla MedicalHWK2024-08-21
B756STR00117SP1Shukla Trephine S9TREPHINEShukla MedicalHWK2024-08-21
B756STR00118SP1Shukla Trephine S9TREPHINEShukla MedicalHWK2024-08-21
B756STR00119SP1Shukla Trephine S9TREPHINEShukla MedicalHWK2024-08-21
B756STR00120SP1Shukla Trephine S9TREPHINEShukla MedicalHWK2024-08-21
B756STR00121SP1Shukla Trephine S9TREPHINEShukla MedicalHWK2024-08-21