IMPlate

FDA UDI

Class II (US FDA UDI)

by Skeletal Dynamics L.l.c.

Identity

Trade Name: IMPlate FDA UDI
Generic Name: Surgical drill guide, reusable FDA UDI
Model / Reference: IMPLATE Lock Screw, Unicort. Drill Guide FDA UDI

Identifiers

Catalog Number: IMP-UDG-LKSC FDA UDI
Primary DI / UDI-DI: 00841506102214 FDA UDI
510(k) Number: K092720 FDA UDI
FDA Product Code: HSB FDA UDI
GMDN Term: Surgical drill guide, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3020 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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Surgical drill guide, reusable

IMPlate by Skeletal Dynamics L.l.c. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical drill guide, reusable.

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Medtronic Resuable Instruments — MEDTRONIC SOFAMOR DANEK, INC. · Class I
Truliant — Exactech, Inc. · Class II
Vantage — Exactech, Inc. · Class II
Legion — Smith & Nephew, Inc. · Class II
Hintermann Series — Dt Medtech, LLC · Class I
ACUFEX — Smith & Nephew, Inc. · Class I

Cleared under the same submission

K092720 also covers:

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 II	Pending data

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Manufacturer

Manufacturer: Skeletal Dynamics L.l.c.

Sources (1)

FDA UDI 01a0a7fb-6a86-47c9-8697-071999f24d2a 35 fields · synced May 30, 2026