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Tornier Flex

FDA UDI

Class I (US FDA UDI)

by Tornier, Inc.

Identity

Trade Name
Tornier Flex FDA UDI
Generic Name
Surgical implant/trial-implant/sizer holder, reusable FDA UDI
Device Name
Reversed Stem Inserter FDA UDI
Model / Reference
MWF630 FDA UDI
Description
Reversed Stem Inserter FDA UDI

Identifiers

Catalog Number
MWF630 FDA UDI
Primary DI / UDI-DI
03700386977473 FDA UDI
FDA Product Code
LXH FDA UDI
GMDN Term
Surgical implant/trial-implant/sizer holder, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
888.4540 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Surgical implant/trial-implant/sizer holder, reusable

The Tornier Flex hand-held manual surgical instrument is a versatile and reliable tool used in orthopedic and ear/nose/throat (ENT) surgery to connect, gauge, size, and monitor implants, trial instruments, or implantable devices.

Similar devices

Also classified as Surgical implant/trial-implant/sizer holder, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Tornier, Inc.

Sources (1)

  • FDA UDI 4bae3400-ff7c-4e77-8908-66061f7effb6 35 fields · synced Jul 1, 2026