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FDA 510(k)

PARAMOUNT R IBF DEVICE

K-Number: K103228 · 2011-01-05

ApplicantTheken Spine, LLC
Decision Date2011-01-05
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PARAMOUNT R IBF DEVICE 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 2011-01-05 under 510(k) number K103228. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PARAMOUNT R IBF DEVICE?

PARAMOUNT R IBF DEVICE is a medical device that received FDA 510(k) clearance on 2011-01-05. The listed applicant is Theken Spine, LLC. The 510(k) number is K103228.

When did PARAMOUNT R IBF DEVICE receive FDA 510(k) clearance?

PARAMOUNT R IBF DEVICE received FDA 510(k) clearance on 2011-01-05, under 510(k) number K103228.

Who is the listed applicant for PARAMOUNT R IBF DEVICE?

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 PARAMOUNT R IBF DEVICE?

The FDA product code for PARAMOUNT R IBF DEVICE is MAX.

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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.

K121482INSTRUMENT SYSTEM FOR ENDOSCOPIC SPINAL SURGERYK121211VU APOD INTERVERTEBRAL BODY FUSION DEVICEK120829STAINLESS STEEL SPINAL SYSTEMK120047CORAL SPINAL SYSTEMK111675VU C*POD INTERVERTEBRAL BODY FUSION DEVICEK102323CERVICAL STANDALONE INTERVERTEBRAL BODY FUSION DEVICE

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Related Devices (Code: MAX)

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.

K261049SCALA® TLSpineart SAK261430TruLift Expandable SystemLife Spine, Inc.K253011Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer; Meridian Interbody System; Meridian Anterior Plate System; Reef L Interbody System; Reef TO/TA System; Regatta Lateral System; Regatta Lateral Plate System; Shoreline ACS Interbody System; Shoreline Threaded TruProfile Plate; Shoreline RT Interbody System; Vu Mesh; WaveForm A Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TA Interbody System; WaveForm TO Interbody SySeaSpine Orthopedics CorporationK253151Fule Interbody Fusion Cage SystemBeijing Fule Science & Technology Development Co., Ltd.

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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