Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

CERAMIC BALL HEADS, 28, 32 AND 36 MM

K-Number: K070928 · 2007-08-01

ApplicantPlus Orthopedics AG
Decision Date2007-08-01
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CERAMIC BALL HEADS, 28, 32 AND 36 MM is the device name listed in this FDA 510(k) record. The listed applicant is Plus Orthopedics AG. It received FDA 510(k) clearance on 2007-08-01 under 510(k) number K070928. The device is classified under product code LZO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CERAMIC BALL HEADS, 28, 32 AND 36 MM?

CERAMIC BALL HEADS, 28, 32 AND 36 MM is a medical device that received FDA 510(k) clearance on 2007-08-01. The listed applicant is Plus Orthopedics AG. The 510(k) number is K070928.

When did CERAMIC BALL HEADS, 28, 32 AND 36 MM receive FDA 510(k) clearance?

CERAMIC BALL HEADS, 28, 32 AND 36 MM received FDA 510(k) clearance on 2007-08-01, under 510(k) number K070928.

Who is the listed applicant for CERAMIC BALL HEADS, 28, 32 AND 36 MM?

The FDA 510(k) record lists Plus Orthopedics AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CERAMIC BALL HEADS, 28, 32 AND 36 MM?

The FDA product code for CERAMIC BALL HEADS, 28, 32 AND 36 MM is LZO.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Plus Orthopedics AG as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K070731PIGALILEO TOTAL HIP REPLACEMENT (THR) SYSTEMK070278POLARCUP DUAL MOBILITY SYSTEMK063578PROMOS MODULAR SHOULDER SYSTEMK061362PIGALILEO TOTAL KNEE REPLACEMENT (TKR) SYSTEM

Related Devices (Code: LZO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.K253948Momentum Acetabular Cup SystemUnited Orthopedic CorporationK261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KGK260831Z1 Hip SystemZimmer, Inc.K260182Avenir® Müller Stem; Avenir Complete™ Hip SystemZimmer, Inc.K260037implantcast Packaging System UpdateImplantcast GmbH

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑