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FDA 510(k)

S.A.F. ACETABULAR CUP WITH POROUS COATING

K-Number: K896614 · 1990-01-09

ApplicantSynergy Orthopaedics Intl., Inc.
Decision Date1990-01-09
Product CodeJDL
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

S.A.F. ACETABULAR CUP WITH POROUS COATING is the device name listed in this FDA 510(k) record. The listed applicant is Synergy Orthopaedics Intl., Inc.. It received FDA 510(k) clearance on 1990-01-09 under 510(k) number K896614. The device is classified under product code JDL. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the S.A.F. ACETABULAR CUP WITH POROUS COATING?

S.A.F. ACETABULAR CUP WITH POROUS COATING is a medical device that received FDA 510(k) clearance on 1990-01-09. The listed applicant is Synergy Orthopaedics Intl., Inc.. The 510(k) number is K896614.

When did S.A.F. ACETABULAR CUP WITH POROUS COATING receive FDA 510(k) clearance?

S.A.F. ACETABULAR CUP WITH POROUS COATING received FDA 510(k) clearance on 1990-01-09, under 510(k) number K896614.

Who is the listed applicant for S.A.F. ACETABULAR CUP WITH POROUS COATING?

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

What is the FDA product code for S.A.F. ACETABULAR CUP WITH POROUS COATING?

The FDA product code for S.A.F. ACETABULAR CUP WITH POROUS COATING is JDL.

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.

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Other records listing Synergy Orthopaedics Intl., 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.

K895157S.A.F. ACETABULAR CUP

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

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

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