FDA.report

Tecomet

Primary DI
00841435124929
Company
TECOMET INC.
Model
800-08-018
Device description
Adaptor, Male Hex, Female Zimmer-Hall
Published
2026-02-26
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
078749695
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

Identifiers

IdentifierTypeAgencyPackage quantityStatus
00841435124929PrimaryGS10

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityPackage typeContains DIDiscontinue dateStatus
00841435124929PrimaryGS10

Product Codes

CodeNameClassSpecialtyRegulationImplantMalfunction reporting
HTWBit, Drill1Orthopedic888.4540NEligible

Premarket Submissions

No records found.

Premarket Details

No records found.

GMDN Terms

TermDefinition
Orthopaedic implant-instrument extension adaptor, reusableA connecting device designed to join an orthopaedic implant to a surgical instrument, or a surgical instrument to another instrument, typically to create an extension for removal of the implant (e.g., during a percutaneous interspinous distraction procedure for the removal of a distraction sleeve), or to connect two devices with incompatible interfaces. It is typically made from high-grade stainless steel and/or synthetic material and is available in a variety of sizes and lengths. This is a reusable device.

Device Sizes

No records found.

Storage And Handling

No records found.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
262-925-4531julie.davis@tecomet.com

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00841435124912TecometAR-9938-112025-09-05
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00841435111127Tecomet482422025-08-27
00841435111134Tecomet482442025-08-27
00841435111141Tecomet482452025-08-27
00841435111158Tecomet482462025-08-27
00841435111165Tecomet482542025-08-27
00841435111172Tecomet482482025-08-27
00841435111189Tecomet482592025-08-27
00841435111202Tecomet482692025-08-27
00841435118263Tecomet004819011002025-08-27
00841435118287Tecomet004819014002025-08-27
00841435118317TecometK000-20102025-08-27
00841435111196Tecomet482622023-07-13

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