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FDA 510(k)

SPINALATOR JS-1100 TRACTION UNIT

K-Number: K893168 · 1989-05-26

ApplicantThe Spinalator Co.
Decision Date1989-05-26
Product CodeITH
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

SPINALATOR JS-1100 TRACTION UNIT is the device name listed in this FDA 510(k) record. The listed applicant is The Spinalator Co.. It received FDA 510(k) clearance on 1989-05-26 under 510(k) number K893168. The device is classified under product code ITH. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPINALATOR JS-1100 TRACTION UNIT?

SPINALATOR JS-1100 TRACTION UNIT is a medical device that received FDA 510(k) clearance on 1989-05-26. The listed applicant is The Spinalator Co.. The 510(k) number is K893168.

When did SPINALATOR JS-1100 TRACTION UNIT receive FDA 510(k) clearance?

SPINALATOR JS-1100 TRACTION UNIT received FDA 510(k) clearance on 1989-05-26, under 510(k) number K893168.

Who is the listed applicant for SPINALATOR JS-1100 TRACTION UNIT?

The FDA 510(k) record lists The Spinalator Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SPINALATOR JS-1100 TRACTION UNIT?

The FDA product code for SPINALATOR JS-1100 TRACTION UNIT is ITH.

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Related Devices (Code: ITH)

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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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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