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FDA 510(k)

OTI MODULAR SHOULDER SYSTEM

K-Number: K982886 · 1998-10-05

ApplicantOsteoimplant Technology, Inc.
Decision Date1998-10-05
Product CodeHSD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OTI MODULAR SHOULDER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Osteoimplant Technology, Inc.. It received FDA 510(k) clearance on 1998-10-05 under 510(k) number K982886. The device is classified under product code HSD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OTI MODULAR SHOULDER SYSTEM?

OTI MODULAR SHOULDER SYSTEM is a medical device that received FDA 510(k) clearance on 1998-10-05. The listed applicant is Osteoimplant Technology, Inc.. The 510(k) number is K982886.

When did OTI MODULAR SHOULDER SYSTEM receive FDA 510(k) clearance?

OTI MODULAR SHOULDER SYSTEM received FDA 510(k) clearance on 1998-10-05, under 510(k) number K982886.

Who is the listed applicant for OTI MODULAR SHOULDER SYSTEM?

The FDA 510(k) record lists Osteoimplant Technology, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OTI MODULAR SHOULDER SYSTEM?

The FDA product code for OTI MODULAR SHOULDER SYSTEM is HSD.

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Other records listing Osteoimplant Technology, Inc. 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.

K040685Z - SERIES MODULAR TOTAL HIP SYSTEM PLASMA COATEDK041443OTI ALUMINA CERAMIC FEMORAL HEAD SYSTEMK040225OTI ALUMINA CERAMIC FEMORAL HEAD SYSTEMK032729Z-SERIES MODULAR TOTAL HIP SYSTEMK030608OTI BONE CEMENT PLUGK022779OTI UNICONDULAR INTERPOSITIONAL SPACER

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Related Devices (Code: HSD)

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.

K233260Univers Revers CA Head and AdapterArthrex, Inc.K221232Univers Revers Humeral Cup ImplantArthrex, Inc.K191433AGILON® XO Shoulder Replacement SystemImplantcast GmbHK193122Biocore9 Humeral Resurfacing SystemBiocore9, LLCK173964OVOMotion Shoulder Arthroplasty SystemArthrosurface, Inc.K161782Arthrex Univers Revers Shoulder Prosthesis SystemArthrex, Inc.

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.

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