Zuma

FDA UDI

Class I (US FDA UDI)

by SeaSpine Orthopedics Corporation

Identity

Trade Name: Zuma FDA UDI
Generic Name: Orthopaedic surgical distractor, internal FDA UDI
Device Name: Paddle Distractor, 12mm FDA UDI
Model / Reference: 95-5612 FDA UDI
Description: Paddle Distractor, 12mm FDA UDI

Identifiers

Catalog Number: 95-5612 FDA UDI
Primary DI / UDI-DI: 10889981097202 FDA UDI
FDA Product Code: LXH FDA UDI
GMDN Term: Orthopaedic surgical distractor, internal 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

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Orthopaedic surgical distractor, internal

Zuma by SeaSpine Orthopedics Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic surgical distractor, internal.

Sigma — ALPHATEC SPINE, INC. · Class I
APEX 3D Total Ankle Replacement System — Paragon 28 · Class I
EVEREST Spinal System — K2M, INC. · Class I
Medtronic Reusable Instruments — MEDTRONIC SOFAMOR DANEK, INC. · Class I
Medtronic Reusable Instruments — MEDTRONIC SOFAMOR DANEK, INC. · Class I
Medtronic Reusable Instruments — MEDTRONIC SOFAMOR DANEK, INC. · Class I
APEX 3D Total Ankle Replacement System — Paragon 28 · Class I
Medtronic Resuable Instruments — MEDTRONIC SOFAMOR DANEK, INC. · Class I

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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

Manufacturer

Manufacturer: SeaSpine Orthopedics Corporation

Sources (1)

FDA UDI 5b5597d0-e1a1-44cd-bd21-4ea72cf609c7 36 fields · synced Jun 8, 2026