FDA.report

Asym Pat Drill Gde - 34mm

Primary DI
00889024581906
Company
Biomet Orthopedics, LLC
Model
SSI005440
Catalog number
SSI005440
Published
2020-02-03
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
false

Related Records

Regulatory Flags

DUNS number
129278169
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Identifiers

IdentifierTypeAgencyPackage quantityStatus
00889024581906PrimaryGS10

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityPackage typeContains DIDiscontinue dateStatus
00889024581906PrimaryGS10

Product Codes

CodeNameClassSpecialtyRegulationImplantMalfunction reporting
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer2Orthopedic888.3560YEligible

Premarket Submissions

SubmissionSupplement
K110362000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K110362000VANGUARD ASYMMETRICAL PATELLAR COMPONENTBiomet Manufacturing Corp2011-02-28JWH

GMDN Terms

TermDefinition
Surgical drill guide, reusableA hand-held tubular surgical device designed to simultaneously place, angle, and guide a rotating surgical drill on hard tissue (e.g., bone), and to protect the surrounding soft tissue while the drill is in operation. It may have serrations at its distal end to enable firm placement on hard tissue surfaces (it is not bored into the tissue); it can have a handle at its proximal end for holding and manipulation, or it may be held by another device (e.g., orthopaedic jig). The device is typically dedicated to drill bit size, made of metal, and may have graduations along its length; it is not custom-made for a specific patient. This is a reusable device.

Device Sizes

TypeValueText
Device Size Text, specify034mm

Storage And Handling

No records found.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
1 (800) 343-9500customerservice@zimmerbiomet.com

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