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Novation

FDA UDI

Class II (US FDA UDI)

by Exactech, Inc.

Identity

Trade Name
Novation FDA UDI
Generic Name
Orthopaedic inorganic implant inserter/extractor, reusable FDA UDI
Device Name
LINER EXTRACTOR, NOVATION FDA UDI
Model / Reference
181-16-00 FDA UDI
Description
LINER EXTRACTOR, NOVATION FDA UDI

Identifiers

Catalog Number
181-16-00 FDA UDI
Primary DI / UDI-DI
10885862038609 FDA UDI
510(k) Number
K032964 FDA UDI
K040601 FDA UDI
K041906 FDA UDI
K050398 FDA UDI
K051556 FDA UDI
K051682 FDA UDI
K060107 FDA UDI
K071676 FDA UDI
K121392 FDA UDI
K173583 FDA UDI
K182502 FDA UDI
K993082 FDA UDI
FDA Product Code
LWJ FDA UDI
MEH FDA UDI
LPH FDA UDI
KWZ FDA UDI
LZO FDA UDI
OQI FDA UDI
JDI FDA UDI
GMDN Term
Orthopaedic inorganic implant inserter/extractor, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3360 FDA UDI
888.3353 FDA UDI
888.3358 FDA UDI
888.3310 FDA UDI
888.3350 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

Category: Orthopaedic inorganic implant inserter/extractor, reusable

Novation by Exactech, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic inorganic implant inserter/extractor, reusable.

Cleared under the same submission

K032964 also covers:

K041906 also covers:

K050398 also covers:

K051556 also covers:

K051682 also covers:

K060107 also covers:

K071676 also covers:

K121392 also covers:

K173583 also covers:

K182502 also covers:

K993082 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Exactech, Inc.

Sources (1)

  • FDA UDI 81f542b1-e17c-4f70-ab38-ee5232be7f3e 35 fields · synced Jun 8, 2026