Aesculap T-Space PEEK and XP Spinal System

Q: What is the product code of K151056?

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) K151056 · Aesculap Implant Systems, LLC

Substantially Equivalent

510(k) numberK151056

Submission

Device name: Aesculap T-Space PEEK and XP Spinal System
Applicant: Aesculap Implant Systems, LLC
Center Valley, PA, US
Received: April 20, 2015
Decision date: August 13, 2015
Decision: Substantially Equivalent (SESE)
Type: Traditional 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

510(k)	Device	Applicant	Decision
K261049	Scala® TLMAX · Traditional	Spineart SA	08/20/2026SE
K261430	TruLift Expandable SystemMAX · Traditional	Life Spine, Inc.	07/28/2026SE
K253011	Catalyft PL Expandable Interbody SystemMAX · Traditional	Medtronic Sofamor Danek USA, Inc.	07/17/2026SE
K261020	Symmetrix L Spinal SystemMAX · Traditional	Medtronic Sofamor Danek USA, Inc.	07/14/2026SE
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
K213871	Ennovate Cervical Spinal and Occiput SystemNKG · Traditional	07/01/2022SE
K210963	ENNOVATE Spinal SystemNKB · Traditional	07/19/2021SE
K180433	Ennovate®NKB · Traditional	04/26/2018SE
K162134	ENNOVATE Spinal SystemNKB · Traditional	12/14/2016SE
K153700	Aesculap(R) Implant Systems (AIS) S4 Navigation InstrumentsOLO · Traditional	07/08/2016SE
K153629	ArcadiusXP C Spinal SystemOVE · Traditional	05/25/2016SE
K153396	Aesculap OrthoPilot Next GenerationOLO · Traditional	05/16/2016SE
K151938	S4 Cervical Spinal and Occiput SystemsNKG · Traditional	10/21/2015SE
K150544	Columbus Total Knee System, Columbus Revision Knee System, EnduRo Knee SystemJWH · Special	05/29/2015SE
K141694	Aesculap Orthopilot Next GenerationOLO · Special	02/24/2015SE

Questions and answers

When was Aesculap T-Space PEEK and XP Spinal System cleared by the FDA?

Aesculap T-Space PEEK and XP Spinal System (K151056) received a 510(k) decision of Substantially Equivalent on August 13, 2015, 115 days after the submission was received.

What is the product code of K151056?

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.