Equinoxe

FDA UDI

Class II (US FDA UDI)

by Exactech, Inc.

Identity

Trade Name: Equinoxe FDA UDI
Generic Name: Bone-resection orthopaedic reamer, reusable FDA UDI
Device Name: CALCAR PLANER BLADE 53MM FDA UDI
Model / Reference: 301-09-53 FDA UDI
Description: CALCAR PLANER BLADE 53MM FDA UDI

Identifiers

Catalog Number: 301-09-53 FDA UDI
Primary DI / UDI-DI: 10885862542069 FDA UDI
510(k) Number: K042021 FDA UDI
K063569 FDA UDI
K082702 FDA UDI
K102951 FDA UDI
K121067 FDA UDI
K140063 FDA UDI
K162726 FDA UDI
FDA Product Code: PHX FDA UDI
HSD FDA UDI
KWT FDA UDI
KWS FDA UDI
GMDN Term: Bone-resection orthopaedic reamer, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3660 FDA UDI
888.3690 FDA UDI
888.3650 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

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size: Outer Diameter — 53 Millimeter FDA UDI

Category: Bone-resection orthopaedic reamer, reusable

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

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Also classified as Bone-resection orthopaedic reamer, reusable.

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Trigen — Smith & Nephew, Inc. · Class I
DJO SURGICAL — ENCORE MEDICAL, L.P. · Class I
Made-To-Order — TORNIER, INC. · Class I
LINK Instruments - Drills, reamers and saw blades — WALDEMAR LINK GmbH & Co. KG · Class I

Cleared under the same submission

K042021 also covers:

K063569 also covers:

K082702 also covers:

K102951 also covers:

K121067 also covers:

K140063 also covers:

K162726 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: Exactech, Inc.

Sources (1)

FDA UDI 9f0737a3-2e1e-4e88-8bb6-11b70a0c2ee4 36 fields · synced May 31, 2026