FDA.report

Sterile Spine Pedicle Screw System

Primary DI
B5627720510
Brand
Sterile Spine Pedicle Screw System
Company
WISHBONE MEDICAL, INC.
Model
77.2051
Catalog number
77.2051
Device description
Adaptor, Torque Limiting, 1/4 sq., 110 in/lbs.
Published
2023-02-02
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
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications

CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B5627720510PrimaryHIBCC0

GMDN Terms

TermDefinition
Orthopaedic implant/instrument assembling deviceA non-sterile, noninvasive tool designed to support assembly of the component parts of an orthopaedic implant or surgical instrument during an orthopaedic surgical procedure, typically when component sizes are determined during the procedure [e.g., stem, neck, and head femoral components of a total hip arthroplasty (THA)]. It is available in one of a variety of forms (e.g., holder, clamp/press), however it is not a component of the final instrument/implant and is not a surgical screwdriver or wrench. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
(574) 306-4006CustomerService@wishbonemedical.com

Regulatory Flags

DUNS number
062355158
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
true

Other Devices From This Company

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B562PKGS000100Micro Surgery KitPK-GS0001PK-GS00012024-12-30
B562PKGS000200Minor Surgery KitPK-GS0002PK-GS00022024-12-30
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B56211705335200S0Smart Correction11-705-335200S11-705-335200S2023-06-23
B56211705340200S0Smart Correction11-705-340200S11-705-340200S2023-06-23
B56211705345200S0Smart Correction11-705-345200S11-705-345200S2023-06-23
B56211705350200S0Smart Correction11-705-350200S11-705-350200S2023-06-23
B56211705410200S0Smart Correction11-705-410200S11-705-410200S2023-06-23
B56211705415200S0Smart Correction11-705-415200S11-705-415200S2023-06-23
B56211705420200S0Smart Correction11-705-420200S11-705-420200S2023-06-23
B56211705425200S0Smart Correction11-705-425200S11-705-425200S2023-06-23
B56211705430200S0Smart Correction11-705-430200S11-705-430200S2023-06-23
B56211705435200S0Smart Correction11-705-435200S11-705-435200S2023-06-23
B56211705440200S0Smart Correction11-705-440200S11-705-440200S2023-06-23
B56211705445200S0Smart Correction11-705-445200S11-705-445200S2023-06-23

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