Redondo-L

Q: When was Redondo-L cleared by the FDA?

Redondo-L (K103297) received a 510(k) decision of Substantially Equivalent on January 27, 2011, 80 days after the submission was received.

Q: What is the product code of K103297?

The FDA product code is MAX – Intervertebral Fusion Device With Bone Graft, Lumbar, a Class II (moderate risk) device regulated under 21 CFR 888.3080.

FDA 510(k) K103297 · Seaspine, Inc.

Substantially Equivalent

510(k) numberK103297

Submission

Device name: Redondo-L
Applicant: Seaspine, Inc.
Vista, CA, US
Received: November 8, 2010
Decision date: January 27, 2011
Decision: Substantially Equivalent (SESE)
Type: Special 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: MAX – Intervertebral Fusion Device With Bone Graft, Lumbar
Device class: Class II (moderate risk)
Regulation: 21 CFR 888.3080
Specialty: Orthopedic
Implant: Yes

Intended to stabilize spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.

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K253894	BMD Titanium Spinal Fusion SystemMAX · Traditional	Global Biomedica s.r.o.	05/28/2026SE
K260506	Ventana® P/T Lumbar Interbody SystemMAX · Traditional	Spinal Elements, Inc.	05/15/2026SE
K260837	VersaLift Expandable SystemMAX · Traditional	Life Spine, Inc.	05/12/2026SE

More from Life Spine, Inc.

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K150469	Integra Laminoplasty SystemNQW · Special	03/23/2015SE
K142488	SeaSpine Spacer System - (Hollywood, Pacifica, Redondo, Ventura) NanoMetalene, Cambria…MAX · Traditional	12/18/2014SE
K133418	Integra Expandable Interverebral Body Fusion Device (Ibd) SystemMAX · Traditional	05/01/2014SE
K132859	Integra Facet Fixation SystemMRW · Traditional	11/18/2013SE
K121924	Integra Interspinous Process SystemPEK · Traditional	09/04/2013SE
K130830	Integra Laminoplasty SystemNQW · Traditional	05/09/2013SE
K122571	Malibu Spinal System with the Daytona Deformity SystemNKB · Special	12/12/2012SE
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Questions and answers

When was Redondo-L cleared by the FDA?

Redondo-L (K103297) received a 510(k) decision of Substantially Equivalent on January 27, 2011, 80 days after the submission was received.

What is the product code of K103297?

The FDA product code is MAX – Intervertebral Fusion Device With Bone Graft, Lumbar, a Class II (moderate risk) device regulated under 21 CFR 888.3080.