FDA.reportPublic FDA data

INBONE™

Primary DI
00889797075572
Brand
INBONE™
Company
WRIGHT MEDICAL TECHNOLOGY, INC.
Model
66503218
Catalog number
66503218
Device description
Hole Saw
Published
2022-11-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HSOSAW

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSOSawGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889797075572PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889797075572008897970755728897970755720889797075572

GMDN Terms#

Term, Definition table
TermDefinition
General internal orthopaedic fixation system implantation kitA collection of instruments and devices intended to be used for the placement of an internal orthopaedic fixation system into or onto all types of bones (e.g., bones of limbs, spine, pelvis, or craniomaxillofacial). It is a non-dedicated device that includes various metallic and/or plastic reusable devices [e.g., retractors, rods, clamps, drills, pins, saws, screwdrivers, guides, trials, impactors] intended to be used for the implantation of any type of internal orthopaedic fixation system; the implant(s) is not included. This is a reusable device.

Device Sizes#

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)238-7117customerservice@wmt.com

Regulatory Flags#

DUNS number
807201207
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889797076586INVISION60004403600044032022-05-31
00840420167606INVISION600044032016-02-26
00840420106254DARCODC0043162015-10-01
00840420106261DARCODC0043182015-10-01
00840420106278DARCODC0043202015-10-01
00840420106285DARCODC0043222015-10-01
00840420106292DARCODC0043242015-10-01
00889797023443INVISION600025012016-09-17
00889797024136INVISION600124002016-09-17
00889797024143INVISION600124012016-09-17
00889797040686NA49411XL2016-09-17
00889797040693NA49412XL2016-09-17
00889797040709NA49413XL2016-09-17
00889797057295EZ FRAMEEF0037002015-10-24
00889797058452EZ FRAME SIDEKICKEF0016002016-09-17
00889797102957NAEF002550EF0025502022-06-23
00889797103084NAEF003005EF0030052022-06-23
00889797103107NAEF003700EF0037002022-06-23
00889797103091NAEF003010EF0030102022-06-23
00889797103046NAEF001600EF0016002022-05-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810055254040Surgical DesignSurgical Design, Inc.HSO2026-04-21
00889797112666N/AWRIGHT MEDICAL TECHNOLOGY, INC.HSO2025-08-26
00889797112673N/AWRIGHT MEDICAL TECHNOLOGY, INC.HSO2025-08-26
00889797112680N/AWRIGHT MEDICAL TECHNOLOGY, INC.HSO2025-08-26
00889797112697N/AWRIGHT MEDICAL TECHNOLOGY, INC.HSO2025-08-26
00889797112703N/AWRIGHT MEDICAL TECHNOLOGY, INC.HSO2025-08-26
00887482036730Symmetry SatterleeASPEN SURGICAL PRODUCTS, INC.HSO2024-08-12
G586N8813340Novo SurgicalNOVO SURGICAL, INC.HSO2023-12-18
G586N8815810Novo SurgicalNOVO SURGICAL, INC.HSO2023-12-18
G586N8816470Novo SurgicalNOVO SURGICAL, INC.HSO2023-12-18
G586N98813340Novo SurgicalNOVO SURGICAL, INC.HSO2023-12-18
G586N98814380Novo SurgicalNOVO SURGICAL, INC.HSO2023-12-18
G586N98814760Novo SurgicalNOVO SURGICAL, INC.HSO2023-12-18
G586N98815810Novo SurgicalNOVO SURGICAL, INC.HSO2023-12-18
G586N98816460Novo SurgicalNOVO SURGICAL, INC.HSO2023-12-18
G586N98816480Novo SurgicalNOVO SURGICAL, INC.HSO2023-12-18
07540194014245FASSIER-DUVAL TELESCOPIC IM SYSTEMOrthopediatrics Canada ULCHSO2023-11-16
00819034027019DynaBridgeFUSION ORTHOPEDICS, LLCHSO2023-07-03
00819034029693DynaBridgeFUSION ORTHOPEDICS, LLCHSO2023-07-03
00840124507074LapiLockFUSION ORTHOPEDICS, LLCHSO2023-07-03
00840124507081LapiLockFUSION ORTHOPEDICS, LLCHSO2023-07-03
00840124507364LapiLockFUSION ORTHOPEDICS, LLCHSO2023-07-03
00840124507371LapiLockFUSION ORTHOPEDICS, LLCHSO2023-07-03
00819034027002DynaBridgeFUSION ORTHOPEDICS, LLCHSO2023-06-16
00840124507388DynaBridgeFUSION ORTHOPEDICS, LLCHSO2023-06-16
00889797075527INBONE™WRIGHT MEDICAL TECHNOLOGY, INC.HSO2022-11-16
00889797075534INBONE™WRIGHT MEDICAL TECHNOLOGY, INC.HSO2022-11-16
00889797075541INBONE™WRIGHT MEDICAL TECHNOLOGY, INC.HSO2022-11-16
00889797075558INBONE™WRIGHT MEDICAL TECHNOLOGY, INC.HSO2022-11-16
00889797075565INBONE™WRIGHT MEDICAL TECHNOLOGY, INC.HSO2022-11-16