← Back to catalogue

ZipTight™ Fixation System

FDA UDI

Class I (US FDA UDI)

by Biomet Orthopedics, Inc.

Identity

Trade Name
ZipTight™ Fixation System FDA UDI
Generic Name
Ligament reconstruction instrument set, reusable FDA UDI
Model / Reference
904837 FDA UDI

Identifiers

Catalog Number
904837 FDA UDI
Primary DI / UDI-DI
00880304491885 FDA UDI
FDA Product Code
LXH FDA UDI
GMDN Term
Ligament reconstruction instrument set, 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

Yes

FDA UDI

Single Use

Yes

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Ligament reconstruction instrument set, reusable

ZipTight™ Fixation System by Biomet Orthopedics, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Ligament reconstruction instrument set, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Biomet Orthopedics, Inc.

Sources (1)

  • FDA UDI a61e8f32-a67a-4579-8c2a-dd7a938f3562 34 fields · synced May 31, 2026