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FDA 510(k)

INSTRUMENT SYSTEM FOR ENDOSCOPIC SPINAL SURGERY

K-Number: K121482 · 2012-08-28

ApplicantTheken Spine, LLC
Decision Date2012-08-28
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

INSTRUMENT SYSTEM FOR ENDOSCOPIC SPINAL SURGERY is the device name listed in this FDA 510(k) record. The listed applicant is Theken Spine, LLC. It received FDA 510(k) clearance on 2012-08-28 under 510(k) number K121482. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INSTRUMENT SYSTEM FOR ENDOSCOPIC SPINAL SURGERY?

INSTRUMENT SYSTEM FOR ENDOSCOPIC SPINAL SURGERY is a medical device that received FDA 510(k) clearance on 2012-08-28. The listed applicant is Theken Spine, LLC. The 510(k) number is K121482.

When did INSTRUMENT SYSTEM FOR ENDOSCOPIC SPINAL SURGERY receive FDA 510(k) clearance?

INSTRUMENT SYSTEM FOR ENDOSCOPIC SPINAL SURGERY received FDA 510(k) clearance on 2012-08-28, under 510(k) number K121482.

Who is the listed applicant for INSTRUMENT SYSTEM FOR ENDOSCOPIC SPINAL SURGERY?

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

What is the FDA product code for INSTRUMENT SYSTEM FOR ENDOSCOPIC SPINAL SURGERY?

The FDA product code for INSTRUMENT SYSTEM FOR ENDOSCOPIC SPINAL SURGERY is HRX.

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Other records listing Theken Spine, LLC 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.

K121211VU APOD INTERVERTEBRAL BODY FUSION DEVICEK120829STAINLESS STEEL SPINAL SYSTEMK120047CORAL SPINAL SYSTEMK111675VU C*POD INTERVERTEBRAL BODY FUSION DEVICEK103228PARAMOUNT R IBF DEVICEK102323CERVICAL STANDALONE INTERVERTEBRAL BODY FUSION DEVICE

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Related Devices (Code: HRX)

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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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