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InCompass®

FDA UDI

Class II (US FDA UDI)

by Zimmer Spine, Inc.

Identity

Trade Name
InCompass® FDA UDI
Generic Name
Bone-screw internal spinal fixation system, non-sterile FDA UDI
Model / Reference
810-450 FDA UDI

Identifiers

Catalog Number
810-450 FDA UDI
Primary DI / UDI-DI
00889024401600 FDA UDI
FDA Product Code
MNH FDA UDI
KWP FDA UDI
GMDN Term
Bone-screw internal spinal fixation system, non-sterile FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3070 FDA UDI
888.3050 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

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

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size
Outer Diameter — 0.25 Inch FDA UDI
Length — 450 Millimeter FDA UDI

Category: Bone-screw internal spinal fixation system, non-sterile

InCompass® by Zimmer Spine, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bone-screw internal spinal fixation system, non-sterile.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Zimmer Spine, Inc.

Sources (1)

  • FDA UDI 402ffae6-ba2e-431f-bd5a-048a688ab93c 35 fields · synced May 30, 2026