Camber Spine Diagon Oblique Cage

Q: What is the product code of K134038?

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) K134038 · Camber Spine

Substantially Equivalent

510(k) numberK134038

Submission

Device name: Camber Spine Diagon Oblique Cage
Applicant: Camber Spine
Newtown Square, PA, US
Received: December 31, 2013
Decision date: March 20, 2014
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.

Other 510(k)s with product code MAX

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K253011	Catalyft PL Expandable Interbody SystemMAX · Traditional	Medtronic Sofamor Danek USA, Inc.	07/17/2026SE
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K253420	Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…MAX · Traditional	SeaSpine Orthopedics Corporation	07/01/2026SE
K253151	Fule Interbody Fusion Cage SystemMAX · Traditional	Beijing Fule Science & Technology Development…	06/15/2026SE
K261159	Exceed® Biplanar Expandable Interbody SystemMAX · Traditional	Spine Wave, Inc.	05/29/2026SE
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.

510(k)	Device	Decision
K143490	VERTA Corpectomy CageMQP · Traditional	01/26/2015SE
K133366	Orthros Posterior Stabilization SystemNKB · Traditional	04/08/2014SE
K133529	Camber Spine Coveris Cervical CageODP · Traditional	03/20/2014SE

Questions and answers

When was Camber Spine Diagon Oblique Cage cleared by the FDA?

Camber Spine Diagon Oblique Cage (K134038) received a 510(k) decision of Substantially Equivalent on March 20, 2014, 79 days after the submission was received.

What is the product code of K134038?

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.