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FDA 510(k)

STRYKER 2115 REPLACEMENT BATTERY (2115)

K-Number: K970378 · 1997-04-30

ApplicantImplant Resource, Inc.
Decision Date1997-04-30
Product CodeKIJ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

STRYKER 2115 REPLACEMENT BATTERY (2115) is the device name listed in this FDA 510(k) record. The listed applicant is Implant Resource, Inc.. It received FDA 510(k) clearance on 1997-04-30 under 510(k) number K970378. The device is classified under product code KIJ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STRYKER 2115 REPLACEMENT BATTERY (2115)?

STRYKER 2115 REPLACEMENT BATTERY (2115) is a medical device that received FDA 510(k) clearance on 1997-04-30. The listed applicant is Implant Resource, Inc.. The 510(k) number is K970378.

When did STRYKER 2115 REPLACEMENT BATTERY (2115) receive FDA 510(k) clearance?

STRYKER 2115 REPLACEMENT BATTERY (2115) received FDA 510(k) clearance on 1997-04-30, under 510(k) number K970378.

Who is the listed applicant for STRYKER 2115 REPLACEMENT BATTERY (2115)?

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

What is the FDA product code for STRYKER 2115 REPLACEMENT BATTERY (2115)?

The FDA product code for STRYKER 2115 REPLACEMENT BATTERY (2115) is KIJ.

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 Implant Resource, 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.

K002125PINS AND WIRES

Related Devices (Code: KIJ)

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.

K163308SMARTOJeil Medical CorporationK112599INSURGICAL SINGLE USE POWER EQUIPMENTInsurgical, LLCK101563SMARTOJeil Medical CorporationK972367STRYKER SYSTEM 4000 HEAVY DUTY BATTERY POWERED EQUIPMENTStryker InstrumentsK960711ACUMED BONE GRAFT SYSTEMAcu Med, Inc.K951450SYSTEM 2000 REPLACEMENT BATTERY, SYSTEM 2000-EXTENDED RUN REPLACEMENT BATTERYStrenumed, 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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