What is FDA product code OWI?

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.

Response 5.5/6.0 Spine · Bone Fixation Cerclage, Sublaminar → Orthopedic

Name: Response 5.5/6.0 Spine
Brand: Response 5.5/6.0 Spine

1manufacturer

2catalogue numbers in this listing

2510(k) clearances naming this product code

1recall

Who Else Makes It

Registered in Shandong. One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code OWI
Manufacturer	City	Province	Registered as	Device types
Shandong Weigao Orthopaedic Device Co., Ltd.	Weihai	Shandong	Contract manufacturer	42

Record

Regulatory record for Response 5.5/6.0 Spine
Listed by	Orthopediatrics, Corp, United States
FDA product code	OWI
Device type	Bone Fixation Cerclage, Sublaminar
Device class	Class 2
Regulation	21 CFR 888.3010
Establishment	Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
510(k)	K150600
Record published	2017-01-15
Record revised	2025-05-14 (version 5)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number
UDI direct marking	Exempt

Catalogue Numbers

Catalogue numbers for Response 5.5/6.0 Spine
Catalogue number	Size	Status
00-1300-6820		In distribution
00-1300-6900		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Jazz System	Implanet	118
Hiline	Globus Medical, Inc.	22
Ligapass	Medicrea International	20
Translace™ Spinal Tethering System	Medtronic Sofamor Danek, Inc.	14
Nile™ Alternative Fixation System	VB Spine LLC	13
Nile™ Proximal Fixation System	VB Spine LLC	13
Universal Clamp ™	Zimmer Spine, Inc.	9
VersaTie	Nuvasive, Inc.	8
Silc	Globus Medical, Inc.	8
Mariner Cap	Seaspine Orthopedics Corporation	7
Jazz Lock	Implanet	6
Invictus	Alphatec Spine, Inc.	5

Showing 12 of 20. All products under Bone Fixation Cerclage, Sublaminar

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K200097	2020-03-16
K161267	2016-08-11

Recalls

1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity	Closed
2017-04-24	Class II	Device Design	Over-tensioning of the band resulting in damage to the band causing it to rupture	82	2017-09-18

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Response 5.5/6.0 Spine