Endo Head

• FDA 510(k) K111145 decided 16 Aug 2011 Active
• FDA GUDID UDI-DI 07630030806407 listed 18 Nov 2014 Listed

1. 16 Aug 2011 Cleared FDA 510(k) K111145
2. 18 Nov 2014 Listed FDA GUDID 07630030806407

Trade name

Endohead

Generic name

Bipolar femoral head outer component, hemiarthroplasty

Model / reference

01.25.246S

FDA applicant

Medacta International

Primary DI / UDI-DI

07630030806407

510(k) Number

K111145 ↗

FDA product code

LZY

GMDN term

Bipolar femoral head outer component, hemiarthroplasty

Device class

Class II

Regulation

21 CFR Part 888.3360

Advisory committee

Orthopedic

FDA decision

SESE Substantially Equivalent

GUDID distribution status

In Commercial Distribution

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Source: 510k-lineage (choiben314), CC BY 4.0

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Other devices filed under FDA product code LZY (Prosthesis, Hip, Hemi-, Femoral, Metal Ball).

• PRE-POWDERED NITRILE EXAMINATION GLOVES by P.T. Latexindo Tobaperkasa
• Taperloc® Microplasty® 33-103204 by Biomet Orthopedics, Inc.
• Taperloc® Microplasty® 33-103212 by Biomet Orthopedics, Inc.
• FEMORAL HEADS/MODULAR & FIXED W/ TITAN NITRIDE SUR by Protek, Inc.
• 1363-10-000 136310000 by DEPUY ORTHOPAEDICS, INC.
• 1363-12-000 136312000 by DEPUY ORTHOPAEDICS, INC.
• Modular Cathcart Fracture System by Depuy, Inc.
• IONGUARD TITANIUM MODULAR HEADS by Biomet, Inc.
• UNI-POLAR HEAD by Richards Medical Co., Inc.
• BHR BIPOLAR FEMORAL HEAD COMPONENT by Implantology Corp.

• Fixed tibial tray cementless S.2R

  Class III

  CE/MDD

• X-Acta Rasp Offset 37.5mm CDH Size 0

  Class I

  CE/MDD

• Flex E-cross trial insert S6L - 13 mm

  Class IIa

  CE/MDD

• Trial Neck Anteverted LAT #2-3 Right

  Class IIa

  CE/MDD

See all devices from Medacta International SA →