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FDA 510(k)

SPINE-TECH BONE HARVESTER

K-Number: K970040 · 1997-02-28

ApplicantSpine-Tech, Inc.
Decision Date1997-02-28
Product CodeHWE
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SPINE-TECH BONE HARVESTER is the device name listed in this FDA 510(k) record. The listed applicant is Spine-Tech, Inc.. It received FDA 510(k) clearance on 1997-02-28 under 510(k) number K970040. The device is classified under product code HWE. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPINE-TECH BONE HARVESTER?

SPINE-TECH BONE HARVESTER is a medical device that received FDA 510(k) clearance on 1997-02-28. The listed applicant is Spine-Tech, Inc.. The 510(k) number is K970040.

When did SPINE-TECH BONE HARVESTER receive FDA 510(k) clearance?

SPINE-TECH BONE HARVESTER received FDA 510(k) clearance on 1997-02-28, under 510(k) number K970040.

Who is the listed applicant for SPINE-TECH BONE HARVESTER?

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

What is the FDA product code for SPINE-TECH BONE HARVESTER?

The FDA product code for SPINE-TECH BONE HARVESTER is HWE.

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Other records listing Spine-Tech, 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.

K980288SPINE-TECH SILHOUETTE SPINAL FIXATION SYSTEMK951268SPINE-TECH MODIFIED LAPAROSCOPIC SPINAL FUSION INSTRUMENT SYSTEMK940913SPINE-TECH LAPAROSCOPIC INSTRUMENTATION SYSTEM

Related Devices (Code: HWE)

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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