OSTEONICS PS HEAD AND NECK HIP STEM SERIES— 510(k) K902712

Name: FDA 510(k) clearance K902712
Creator: U.S. Food and Drug Administration
Published: 1990-08-09

Substantially Equivalent for Some Indications

Osteonics Corp.

FDA 510(k) clearance K902712 for OSTEONICS PS HEAD AND NECK HIP STEM SERIES, Substantially Equivalent for Some Indications on 1990-08-09. Applicant: Osteonics Corp.. Device class: 2.

Clearance details

Applicant: Osteonics Corp.
Product code: Code LZO
Device class: Class 2
Regulation: 21 CFR 888.3353
Advisory panel: Orthopedic
Date received: 1990-06-20
Decision date: 1990-08-09
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Allendale, NJ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LZO

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K253948 — Momentum Acetabular Cup System2026-09-02
K261009 — MobileLink Acetabular Cup System 40mm ID Inserts (various)2026-07-06
K260831 — Z1 Hip System2026-06-16
K260182 — Avenir® Müller Stem; Avenir Complete Hip System2026-04-27
K260037 — implantcast Packaging System Update2026-03-30

More clearances from Osteonics Corp.

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K983657 — OSTEONICS SERIES 7000 AD TIBIAL TRAY2000-04-06
K980070 — OSTEONICS HA-COATED DEVICES1999-07-23
K984375 — OSTEONICS SPINAL SYSTEM - SACRAL OFFSET CONNECTOR ASSEMBLY1999-04-30
K982798 — OSTEONICS ANTERIOR CERVICAL COMPRESSION PLATING SYSTEM1999-03-25
K984585 — OSTEONICS +10 UNIPOLAR ADAPTOR SLEEVE1999-02-24

Adverse events under product code LZO

product code LZO

Death: 17
Injury: 12,942
Malfunction: 1,756
Total: 14,715

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.