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Djo Surgical

FDA UDI

Class I (US FDA UDI)

by Encore Medical, L.p.

Identity

Trade Name
DJO SURGICAL FDA UDI
Generic Name
Intraoperative orthopaedic bone pin/screw, single-use FDA UDI
Device Name
ALTIVATE ANATOMIC AG, CROSS PIN, HW, 2.4 x 85mm, STERILE FDA UDI
Model / Reference
804-09-032 FDA UDI
Description
ALTIVATE ANATOMIC AG, CROSS PIN, HW, 2.4 x 85mm, STERILE FDA UDI

Identifiers

Primary DI / UDI-DI
00190446751373 FDA UDI
FDA Product Code
LXH FDA UDI
GMDN Term
Intraoperative orthopaedic bone pin/screw, single-use 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Intraoperative orthopaedic bone pin/screw, single-use

Djo Surgical by Encore Medical, L.p. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Intraoperative orthopaedic bone pin/screw, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Encore Medical, L.p.

Sources (1)

  • FDA UDI 91333a0c-8999-4a74-9672-c238f2fde150 33 fields · synced May 30, 2026