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Taperloc Complete

FDA UDI

Class II (US FDA UDI)

by Biomet Orthopedics, Inc.

Identity

Trade Name
TAPERLOC COMPLETE FDA UDI
Generic Name
Femoral stem prosthesis trial FDA UDI
Model / Reference
51-200000 FDA UDI

Identifiers

Catalog Number
51-200000 FDA UDI
Primary DI / UDI-DI
00880304481046 FDA UDI
510(k) Number
K101086 FDA UDI
K103755 FDA UDI
K120030 FDA UDI
FDA Product Code
MEH FDA UDI
KWY FDA UDI
LPH FDA UDI
LZO FDA UDI
KWZ FDA UDI
MAY FDA UDI
JDI FDA UDI
LWJ FDA UDI
KWL FDA UDI
OQG FDA UDI
GMDN Term
Femoral stem prosthesis trial FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3353 FDA UDI
888.3390 FDA UDI
888.3358 FDA UDI
888.3310 FDA UDI
888.3350 FDA UDI
888.3360 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: Femoral stem prosthesis trial

Taperloc Complete by Biomet Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Femoral stem prosthesis trial.

Cleared under the same submission

K101086 also covers:

K103755 also covers:

K120030 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Biomet Orthopedics, Inc.

Sources (1)

  • FDA UDI edffbb83-93c7-48d1-99dc-ee3e90549050 36 fields · synced Jun 7, 2026