FDA.reportPublic FDA data

Made-To-Order

Primary DI
00846832096060
Brand
Made-To-Order
Company
TORNIER, INC.
Model
9027286
Catalog number
9027286
Device description
Simpliciti Postless Trial Head
Published
2022-11-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWTTEMPLATE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWTTemplateOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00846832096060PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00846832096060008468320960608468320960600846832096060

GMDN Terms#

Term, Definition table
TermDefinition
Humeral head prosthesis trial, reusableA copy of a final humeral head prosthesis designed to be used before primary or revision implant surgery to validate the proper size of the permanent prosthesis required by the patient, to ensure its proper orientation and positioning, and to verify that the implant site has been cut to the proper dimensions. It has a cup-like ball shape and is available in types such as concentric head fixation, eccentric head fixation, cuff tear arthropathy (CTA), or types for revision surgery. It is typically made of metal and/or polymer. This is a reusable device intended to be sterilized prior to use.

Device Sizes#

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

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
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840338607515Made-To-Order902706990270692026-04-28
00840338604033Tornier HRSARS10252ARS102522025-11-18
00840338604040Tornier HRSARS10253ARS102532025-11-18
00846832068678AEQUALIS™ FLEX REVIVE™ARS742301ARS7423012019-03-04
00846832068685AEQUALIS™ FLEX REVIVE™ARS742302ARS7423022019-03-04
00846832068692AEQUALIS™ FLEX REVIVE™ARS742303ARS7423032019-03-05
00846832068708AEQUALIS™ FLEX REVIVE™ARS742304ARS7423042019-03-04
00846832068715AEQUALIS™ FLEX REVIVE™ARS742305ARS7423052019-03-04
00846832068722AEQUALIS™ FLEX REVIVE™ARS742306ARS7423062019-03-04
00846832068739AEQUALIS™ FLEX REVIVE™ARS742401ARS7424012019-03-04
00846832068746AEQUALIS™ FLEX REVIVE™ARS742402ARS7424022019-03-04
00846832068777AEQUALIS™ FLEX REVIVE™ARS742405ARS7424052019-03-04
00846832068784AEQUALIS™ FLEX REVIVE™ARS742406ARS7424062019-03-04
00846832068814AEQUALIS™ FLEX REVIVE™ARS742501ARS7425012019-03-04
00846832068821AEQUALIS™ FLEX REVIVE™ARS742502ARS7425022019-03-04
00846832068838AEQUALIS™ FLEX REVIVE™ARS742503ARS7425032019-03-04
00846832068845AEQUALIS™ FLEX REVIVE™ARS742504ARS7425042019-03-04
00846832068852AEQUALIS™ FLEX REVIVE™ARS742505ARS7425052019-03-04
00846832068869AEQUALIS™ FLEX REVIVE™ARS742506ARS7425062019-03-04
00846832006588Futura™ FGTFGT-202015-10-16

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