FDA.report

Alteon

Primary DI
10885862594907
Brand
Alteon
Company
Exactech, Inc.
Model
189-03-02
Catalog number
189-03-02
Device description
Alteon Short Tapered Wedge Broach, Chip Breaker Tooth, Size 2
Published
2025-04-30
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

Product Codes

CodeName
HTQBROACH

Product Code Classifications

CodeDeviceSpecialtyClass
HTQBroachOrthopedic1

Premarket Submissions

SubmissionSupplement
K221323000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K221323000Exactech® Alteon® Short Tapered WedgeExactech, Inc.2023-05-19LZO

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10885862594907PrimaryGS10

GMDN Terms

TermDefinition
Orthopaedic broachA surgical instrument that is designed as an elongated, tapered and serrated cutting tool intended for shaping and enlarging holes in bone tissue. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
157565946
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
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

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