FDA.reportPublic FDA data

Tornier Perform Reversed MonoPost Glenoid

Primary DI
00840338607607
Brand
Tornier Perform Reversed MonoPost Glenoid
Company
TORNIER, INC.
Model
MWJ234
Catalog number
MWJ234
Device description
Glenoid Pin Guide
Published
2026-01-21
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
FZXGuide, surgical, instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZXGuide, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840338607607PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840338607607008403386076078403386076070840338607607

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic fixation implant alignment toolA surgical instrument designed to facilitate the correct orientation (alignment) of an orthopaedic fixation implant, implants, or system of implants during orthopaedic surgery. It may be used, e.g., to align a series of bone screws in an implant system for posterior stabilization of the spine, or to align a spinal anatomical fixation implant. It is available in a variety of shapes and sizes and allows the surgeon to engage this device with the implant(s) and align them in the desired configuration. It is typically made of high-grade stainless steel or titanium alloy and will have profiled features to fit into the implant(s) to align them. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Angle20degree
Outer Diameter29Millimeter

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
Manufacturing date on label
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G079INL1160070Inlet Bone Fixation SystemIntelivation, LLCFZX2026-04-17
G079INL1160120Inlet Bone Fixation SystemIntelivation, LLCFZX2026-04-17
08806373887772BENCOX Surgical InstrumentsCorentec Co., LtdFZX2026-01-12
08800089479375Summa Orthopaedics System Surgical InstrumentJeil Medical CorporationFZX2025-12-04
07640332475348CURE 2.0 ACPSpineArt SAFZX2025-11-12
07640375235732PERLA ® TL MISSpineArt SAFZX2025-11-10
G79153202001620G0WishFIXRed Star Contract Manufacturing Inc.FZX2025-10-06
G79153202021615G0WishFIXRed Star Contract Manufacturing Inc.FZX2025-10-06
08800071017462Surgical InstrumentOSTEONIC CO.,Ltd.FZX2025-06-24
08800071017479Surgical InstrumentOSTEONIC CO.,Ltd.FZX2025-06-24
08800071017486Surgical InstrumentOSTEONIC CO.,Ltd.FZX2025-06-24
08800071017493Surgical InstrumentOSTEONIC CO.,Ltd.FZX2025-06-24
08800071017509Surgical InstrumentOSTEONIC CO.,Ltd.FZX2025-06-24
08800071017516Surgical InstrumentOSTEONIC CO.,Ltd.FZX2025-06-24
08800071017523Surgical InstrumentOSTEONIC CO.,Ltd.FZX2025-06-24
08800071084389Surgical InstrumentOSTEONIC CO.,Ltd.FZX2025-06-24
08800071084396Surgical InstrumentOSTEONIC CO.,Ltd.FZX2025-06-24
08800071084402Surgical InstrumentOSTEONIC CO.,Ltd.FZX2025-06-24
08800071084419Surgical InstrumentOSTEONIC CO.,Ltd.FZX2025-06-24
08800071084426Surgical InstrumentOSTEONIC CO.,Ltd.FZX2025-06-24
08800071084433Surgical InstrumentOSTEONIC CO.,Ltd.FZX2025-06-24
G463090799PK0Spine InstrumentsBOXSPINE HOLDINGS, INC.FZX2025-01-16
08800089436033Summa Orthopaedics System Surgical InstrumentJeil Medical CorporationFZX2023-01-17
08800089436040Summa Orthopaedics System Surgical InstrumentJeil Medical CorporationFZX2023-01-17
08800089436057Summa Orthopaedics System Surgical InstrumentJeil Medical CorporationFZX2023-01-17
08800089436064Summa Orthopaedics System Surgical InstrumentJeil Medical CorporationFZX2023-01-17
08800089436071Summa Orthopaedics System Surgical InstrumentJeil Medical CorporationFZX2023-01-17
08800089436088Summa Orthopaedics System Surgical InstrumentJeil Medical CorporationFZX2023-01-17
08800089436095Summa Orthopaedics System Surgical InstrumentJeil Medical CorporationFZX2023-01-17
08800089436101Summa Orthopaedics System Surgical InstrumentJeil Medical CorporationFZX2023-01-17