FDA.reportPublic FDA data

Tornier Perform® Reversed Glenoid

Primary DI
00846832091614
Brand
Tornier Perform® Reversed Glenoid
Company
TORNIER, INC.
Model
DWJ001
Catalog number
DWJ001
Published
2022-05-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KWSPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer CementedOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00846832091614PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00846832091614008468320916148468320916140846832091614

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw, non-bioabsorbable, sterileA small, sterile, threaded rod with a slotted head typically used for internal orthopaedic fracture fixation by being screwed into bone to hold plates or nails to bone or to provide direct interfragmentary stabilization of bone, or it may fasten soft tissue to bone; it is made of a material that cannot be chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). There are a number of kinds available: cortical, cancellous, malleolar, scaphoid, partially-threaded and fully-threaded, self-tapping, and cannulated. A "lag screw" can be any of these used to obtain compression across bone fragments.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length7Millimeter

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

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

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
00889024706828Mini Baseplate Sizer Cannulated HandleBiomet Orthopedics, LLCKWS2026-03-19
00889024706835Mini Baseplate Sizer 0 degree On-axis HandleBiomet Orthopedics, LLCKWS2026-03-19
10885862648549EquinoxeExactech, Inc.KWS2026-03-19
10885862648556EquinoxeExactech, Inc.KWS2026-03-19
10885862648563EquinoxeExactech, Inc.KWS2026-03-19
10885862656582EquinoxeExactech, Inc.KWS2026-02-09
00840338607669Tornier Perform Reversed MonoPost GlenoidTORNIER, INC.KWS2026-01-21
00840338607713Tornier Perform Reversed MonoPost GlenoidTORNIER, INC.KWS2026-01-21
00840338607720Tornier Perform Reversed MonoPost GlenoidTORNIER, INC.KWS2026-01-21
00840338612342Tornier Perform Reversed MonoPost GlenoidTORNIER, INC.KWS2026-01-21
00840338612366Tornier Perform Reversed MonoPost GlenoidTORNIER, INC.KWS2026-01-21
00840338612373Tornier Perform Reversed MonoPost GlenoidTORNIER, INC.KWS2026-01-21
00840338612380Tornier Perform Reversed MonoPost GlenoidTORNIER, INC.KWS2026-01-21
00889024692794Augmented BP Reamer Guide ExtractorBiomet Orthopedics, LLCKWS2025-12-18
00889024703742Versa-Dial® Shoulder SystemBiomet Orthopedics, LLCKWS2025-12-09
00885556919354AETOS Shoulder SystemSmith & Nephew, Inc.KWS2025-11-17
00889024691476Identity HumeralZimmer, Inc.KWS2025-09-22
00889024691445Identity HumeralZimmer, Inc.KWS2025-09-17
00889024691490Identity HumeralZimmer, Inc.KWS2025-09-17
00889024691599Identity HumeralZimmer, Inc.KWS2025-09-17
00889024691605Identity HumeralZimmer, Inc.KWS2025-09-17
00889024691612Identity HumeralZimmer, Inc.KWS2025-09-17
00889024691629Identity HumeralZimmer, Inc.KWS2025-09-17
10885862657527EquinoxeExactech, Inc.KWS2025-09-09
10885862657534EquinoxeExactech, Inc.KWS2025-09-09
10885862657541EquinoxeExactech, Inc.KWS2025-09-09
10885862657558EquinoxeExactech, Inc.KWS2025-09-09
10885862657572EquinoxeExactech, Inc.KWS2025-09-09
10885862657602EquinoxeExactech, Inc.KWS2025-09-09
10885862657626EquinoxeExactech, Inc.KWS2025-09-09