Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

SPLINT IT

K-Number: K972985 · 1997-09-24

ApplicantJeneric/Pentron, Inc.
Decision Date1997-09-24
Product CodeELS
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SPLINT IT is the device name listed in this FDA 510(k) record. The listed applicant is Jeneric/Pentron, Inc.. It received FDA 510(k) clearance on 1997-09-24 under 510(k) number K972985. The device is classified under product code ELS. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPLINT IT?

SPLINT IT is a medical device that received FDA 510(k) clearance on 1997-09-24. The listed applicant is Jeneric/Pentron, Inc.. The 510(k) number is K972985.

When did SPLINT IT receive FDA 510(k) clearance?

SPLINT IT received FDA 510(k) clearance on 1997-09-24, under 510(k) number K972985.

Who is the listed applicant for SPLINT IT?

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

What is the FDA product code for SPLINT IT?

The FDA product code for SPLINT IT is ELS.

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 Jeneric/Pentron, 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.

K020499BOND-3 ADHESIVEK013543BOND-1 C & BK013542DENTIN CONDITIONING AND ADHESIVE SYSTEM (BOND-1)K012231AVANTE MICRO CRYSTAL SYSTEMK011748FIRST FILL R.C.S.K010957QUELL DESENSITIZER

View all 78 devices →

Related Devices (Code: ELS)

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.

K961704MTI-MP TRANSITIONAL IMPLANTS AND MODULAR PROSTHETIC SYSTEMDentatus USA , Ltd.K922673FLEXIBLE CERAMIC ROPES AND TAPES FOR BONDINGGlasspan, Inc.K834363ENDIX RADICULAR BIOCERAMIC PINC.B.S. Biotechnics, Inc.K811209JACOB WIRZ TRANSFIXATION PINColmed, Ltd.K801525ZEST ENDODONTIC STABILIZERZest Anchors, 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.

↑