Response BandLoc Spinal Fixation

Q: What is the product code of K200097?

The FDA product code is OWI – Bone Fixation Cerclage, Sublaminar, a Class II (moderate risk) device regulated under 21 CFR 888.3010.

FDA 510(k) K200097 · OrthoPediatrics Corp.

Substantially Equivalent

510(k) numberK200097

Submission

Device name: Response BandLoc Spinal Fixation
Applicant: OrthoPediatrics Corp.
Warsaw, IN, US
Received: January 16, 2020
Decision date: March 16, 2020
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: OWI – Bone Fixation Cerclage, Sublaminar
Device class: Class II (moderate risk)
Regulation: 21 CFR 888.3010
Specialty: Orthopedic
Implant: Yes

Acts as a bone anchor for temporary stabilization, or used in conjunction with other medical implants of similar metals when wiring is needed, during development of a spinal fusion.

Other 510(k)s with product code OWI

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K261374	LigaPASS SystemOWI · Special	Medicrea International S.A.S	05/27/2026SE
K253615	Invictus Bands SystemOWI · Traditional	Alphatec Spine, Inc.	03/25/2026SE
K222097	OLYMPIC Deformity Band SystemOWI · Traditional	Astura Medical	05/04/2023SE
K230565	HILINE Fixation SystemOWI · Traditional	Globus Medical, Inc.	04/20/2023SE
K213659	LigaPASS 2.0 Ligament Augmentation SystemOWI · Traditional	Medicrea International SA	05/24/2022SE
K211057	LigaPASS® Spinal System, CD Horizon Spinal SystemOWI · Traditional	Medtronic, Inc.	05/27/2021SE
K201240	Mariner Cap SystemOWI · Traditional	SeaSpine Orthopedics Corporation	08/05/2020SE
K200281	The Gecko Spinal SystemOWI · Traditional	Ortho Development Corporation	03/31/2020SE
K191217	Jazz PFOWI · Traditional	Implanet, S.A.	08/02/2019SE
K190289	Karma® Fixation SystemOWI · Traditional	Spinal Elements, Inc.	04/03/2019SE

More from Spinal Elements, Inc.

510(k)	Device	Decision
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K251362	PediFlex Flexible Nail SystemHTY · Traditional	06/24/2025SE
K243963	Pediatric Plating Platform HipHRS · Traditional	04/29/2025SE
K250623	Pediatric Nailing Platform Tibia Pediatric Nailing Platform FemurHSB · Special	04/01/2025SE
K241816	VerteGlide Spinal Growth Guidance SystemPGM · Traditional	03/14/2025SE
K243798	Orthex External Fixation SystemKTT · Traditional	03/07/2025SE
K233105	RESPONSE Rib and Pelvic SystemMDI · Traditional	01/20/2024SE
K231266	Pediatric Nailing Platform TibiaHSB · Traditional	08/21/2023SE
K222105	RESPONSE 5.5/6.0 Cannulated Screw SystemNKB · Special	03/23/2023SE

Questions and answers

When was Response BandLoc Spinal Fixation cleared by the FDA?

Response BandLoc Spinal Fixation (K200097) received a 510(k) decision of Substantially Equivalent on March 16, 2020, 60 days after the submission was received.

What is the product code of K200097?

The FDA product code is OWI – Bone Fixation Cerclage, Sublaminar, a Class II (moderate risk) device regulated under 21 CFR 888.3010.