FDA.report

INBONE™

Primary DI
00889797075558
Brand
INBONE™
Company
WRIGHT MEDICAL TECHNOLOGY, INC.
Model
66503214
Catalog number
66503214
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
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
HSOSAW

Product Code Classifications

CodeDeviceSpecialtyClass
HSOSawGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00889797075558PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00889797075558008897970755588897970755580889797075558

GMDN Terms

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

TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)238-7117customerservice@wmt.com

Regulatory Flags

DUNS number
807201207
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
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
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
00889797023368INVISION600022012016-09-17
00889797023375INVISION600023002016-09-17
00889797023382INVISION600023012016-09-17
00889797023436INVISION600025002016-09-17
00889797023337INVISION600021002016-09-17
00889797023344INVISION600021012016-09-17
00889797023351INVISION600022002016-09-17
00889797107679Made-To-OrderSMS00456SMS004562022-12-08
00889797108188Made-To-OrderSMS00494SMS004942022-12-08

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
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 Surgical®SYMMETRY SURGICAL 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 SYSTEMPega Medical IncHSO2023-11-16
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
00889797075565INBONE™WRIGHT MEDICAL TECHNOLOGY, INC.HSO2022-11-16
00889797075572INBONE™WRIGHT MEDICAL TECHNOLOGY, INC.HSO2022-11-16
00842331188244Novo Surgical Inc. NOVO SURGICAL, INC.HSO2022-11-14