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Exactech

FDA UDI

Class II (US FDA UDI)

by Exactech, Inc.

Identity

Trade Name
Exactech FDA UDI
Generic Name
Orthopaedic implant impactor, reusable FDA UDI
Model / Reference
SK-013517 FDA UDI

Identifiers

Catalog Number
SK-013517 FDA UDI
Primary DI / UDI-DI
10885862515100 FDA UDI
510(k) Number
K070479 FDA UDI
K100269 FDA UDI
K102975 FDA UDI
K122798 FDA UDI
K182502 FDA UDI
K993082 FDA UDI
FDA Product Code
JDI FDA UDI
LPH FDA UDI
LWJ FDA UDI
LZO FDA UDI
MEH FDA UDI
KWZ FDA UDI
OQI FDA UDI
GMDN Term
Orthopaedic implant impactor, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3350 FDA UDI
888.3358 FDA UDI
888.3360 FDA UDI
888.3353 FDA UDI
888.3310 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 implant impactor, reusable

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

Similar devices

Also classified as Orthopaedic implant impactor, reusable.

Cleared under the same submission

K070479 also covers:

K100269 also covers:

K122798 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 34c26978-7490-4fcf-b1aa-570b77119242 34 fields · synced Jun 1, 2026