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FDA 510(k)

OSTEOMARK

K-Number: K961562 · 1996-07-11

ApplicantOstex Intl., Inc.
Decision Date1996-07-11
Product CodeJMM
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

OSTEOMARK is the device name listed in this FDA 510(k) record. The listed applicant is Ostex Intl., Inc.. It received FDA 510(k) clearance on 1996-07-11 under 510(k) number K961562. The device is classified under product code JMM. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OSTEOMARK?

OSTEOMARK is a medical device that received FDA 510(k) clearance on 1996-07-11. The listed applicant is Ostex Intl., Inc.. The 510(k) number is K961562.

When did OSTEOMARK receive FDA 510(k) clearance?

OSTEOMARK received FDA 510(k) clearance on 1996-07-11, under 510(k) number K961562.

Who is the listed applicant for OSTEOMARK?

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

What is the FDA product code for OSTEOMARK?

The FDA product code for OSTEOMARK is JMM.

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 Ostex 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.

K011052OSTEOMARK NTX POINT OF CARE PRESCRIPTION HOME USEK983457OSTEOMARK NTX SERUM EIAK980518OSTEOMARKK945946OSTEOMARK(R)

Related Devices (Code: JMM)

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.

K011052OSTEOMARK NTX POINT OF CARE PRESCRIPTION HOME USEOstex Intl., Inc.K993706ELECSYS SERUM B-CROSSLAPS/SERUM IMMUNOASSAYRoche Diagnostics Corp.K992997OSTEOMARK NTX POCMetrika, Inc.K990843SERUM CROSSLAPS ONE STEP ELISAOsteometer Biotech A/SK983457OSTEOMARK NTX SERUM EIAOstex Intl., Inc.K983674VITROS IMMUNODIAGNOSTIC PRODUCTS: NTX CALIBRATORS, NTX REAGENT PACK, NTX CONTROLSOrtho-Clinical Diagnostics, 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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