Skipjack

FDA UDI

Class I (US FDA UDI)

by SeaSpine Orthopedics Corporation

Identity

Trade Name: Skipjack FDA UDI
Generic Name: Manual bone mill FDA UDI
Device Name: Bone Mill FDA UDI
Model / Reference: 98-4100 FDA UDI
Description: Bone Mill FDA UDI

Identifiers

Catalog Number: 98-4100 FDA UDI
Primary DI / UDI-DI: 10889981138936 FDA UDI
FDA Product Code: LXH FDA UDI
GMDN Term: Manual bone mill 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

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: Manual bone mill

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

Similar devices

Also classified as Manual bone mill.

Neodent — JJGC Indústria e Comércio de Materiais Dentários S/A. · Class I
BONE MILL SET — SONTEC INSTRUMENTS, INC. · Class I
Midas Rex® — Medtronic Powered Surgical Solutions · Class II
Neodent — JJGC Indústria e Comércio de Materiais Dentários S/A. · Class I
BONE MILL — KLS-Martin L.P. · Class I
BONE GRINDER — SONTEC INSTRUMENTS, INC. · Class I
Milling Drum Extra Extra Coarse — Spierings Orthopaedics B.V. · Class I
Hu-Friedy — HU-FRIEDY MFG CO., LLC · 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

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Manufacturer

Manufacturer: SeaSpine Orthopedics Corporation

Sources (1)

FDA UDI 88153d73-3a36-4a02-a9c3-ecf62c25b976 35 fields · synced Jun 8, 2026