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)

SPINAL DISTRACTORS, SPANNERS

K-Number: K882069 · 1988-06-17

ApplicantKarlin Technology, Inc.
Decision Date1988-06-17
Product CodeLXH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SPINAL DISTRACTORS, SPANNERS is the device name listed in this FDA 510(k) record. The listed applicant is Karlin Technology, Inc.. It received FDA 510(k) clearance on 1988-06-17 under 510(k) number K882069. The device is classified under product code LXH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPINAL DISTRACTORS, SPANNERS?

SPINAL DISTRACTORS, SPANNERS is a medical device that received FDA 510(k) clearance on 1988-06-17. The listed applicant is Karlin Technology, Inc.. The 510(k) number is K882069.

When did SPINAL DISTRACTORS, SPANNERS receive FDA 510(k) clearance?

SPINAL DISTRACTORS, SPANNERS received FDA 510(k) clearance on 1988-06-17, under 510(k) number K882069.

Who is the listed applicant for SPINAL DISTRACTORS, SPANNERS?

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

What is the FDA product code for SPINAL DISTRACTORS, SPANNERS?

The FDA product code for SPINAL DISTRACTORS, SPANNERS is LXH.

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 Karlin 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.

K903969SUCTION RETRACTOR(TOWER ATTACH.)FOR CRANK FRAM RETK893203BONE SCREWK893201BONE PLATEK882525SPINAL MICROKNIFEK882519X-RAY MARKERK882073SPINAL NEEDLE

View all 17 devices →

Related Devices (Code: LXH)

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.

K192873SX-One MicroKnifeSonex Health, Inc.K101609SELF RETAINING SOFT TISSUE RETRACTORKoros USA, Inc.K001507MICROPERFORATION INSTRUMENTSmith & Nephew, Inc.K952495ANCHORS AWAY SOFT TISSUE ATTACHMENT SYSTEMOrthopedic Systems, Inc.K943873ORTHOMET ANATOMICALLY GUIDED CARPAL TUNNEL RELEASE SYOrthomet, Inc.K944188SPINAL MARKERLeibinger L.P.

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.

↑