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FDA 510(k)

BIOMETRIC SCREW FIXATION CUP

K-Number: K922861 · 1993-05-12

ApplicantOsteo Technology, Inc.
Decision Date1993-05-12
Product CodeJDL
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BIOMETRIC SCREW FIXATION CUP is the device name listed in this FDA 510(k) record. The listed applicant is Osteo Technology, Inc.. It received FDA 510(k) clearance on 1993-05-12 under 510(k) number K922861. The device is classified under product code JDL. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOMETRIC SCREW FIXATION CUP?

BIOMETRIC SCREW FIXATION CUP is a medical device that received FDA 510(k) clearance on 1993-05-12. The listed applicant is Osteo Technology, Inc.. The 510(k) number is K922861.

When did BIOMETRIC SCREW FIXATION CUP receive FDA 510(k) clearance?

BIOMETRIC SCREW FIXATION CUP received FDA 510(k) clearance on 1993-05-12, under 510(k) number K922861.

Who is the listed applicant for BIOMETRIC SCREW FIXATION CUP?

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

What is the FDA product code for BIOMETRIC SCREW FIXATION CUP?

The FDA product code for BIOMETRIC SCREW FIXATION CUP is JDL.

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Other records listing Osteo 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.

K926156REPLICA(TM) TOTAL HIP SYSTEMK922859ANATOMICAL TYPE KNEE SYSTEMK922869TOTAL CONDYLAT TYPE KNEE SYSTEMK925447OTI ORTHOPEDIC WIRE SYSTEMK926213MODIFIED ZICKEL INTRAMEDULLARY ROD SYSTEMK922870THREE SPIKE CUP

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Related Devices (Code: JDL)

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.

K073499VERSYS EPOCH FULLCOAT HIP PROSTHESIS, MODEL 4088 SERIESZimmer, Inc.K070785DYNASTY ACETABULAR SYSTEMWrightmedicaltechnologyincK061844DYNASTY ACETABULAR SHELL AND COCR ACETABULAR LINERWrightmedicaltechnologyincK051995PROFEMUR RENAISSANCE HIP STEMWrightmedicaltechnologyincK051348CONSERVE TOTAL FEMORAL HEADWrightmedicaltechnologyincK042841M2A/C2A ACETABULAR SYSTEMBiomet, 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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