What is FDA product code PLR?

Vertebral body replacement in the cervical spine.

Palo Alto ™ · Spinal Vertebral Body Replacement Device - Cervical → Orthopedic

Name: Palo Alto ™
Brand: Palo Alto ™

1manufacturer

1catalogue number

1510(k) clearance

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 PLR
Manufacturer	City	Province	Registered as	Device types
Shandong Weigao Orthopaedic Device Co., Ltd.	Weihai	Shandong	Contract manufacturer	42

Record

Regulatory record for Palo Alto ™
Listed by	Cardinal Spine, LLC, United States
FDA product code	PLR
Device type	Spinal Vertebral Body Replacement Device – Cervical
Device class	Class 2
Regulation	21 CFR 888.3060
Record published	2017-06-20
Record revised	2018-03-29 (version 2)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Label carries	lot or batch number, manufacturing date
Sizes	Width 13 mm; depth 12 mm; height 23.25 mm

Catalogue Numbers

Catalogue numbers for Palo Alto ™
Catalogue number	Size	Status
LCM 23.25 MM	23.25 MM LCM-FOOTPRINT 14X13X12 MM	In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Alta	Astura Medical	290
Ascend	Alphatec Spine, Inc.	267
Matrixx System	Nexxt Spine LLC	88
Colosseum	Globus Medical, Inc.	87
Palo Alto Corpectomy Cage System	VB Spine LLC	56
C-VBR	VB Spine LLC	53
Trabis®	Coligne AG	34
X-Core	Nuvasive, Inc.	31
CarboClear Cervical VBR System	CarboFix Orthopedics, Ltd.	31
Capri™ Corpectomy Cage System	VB Spine LLC	25
Zavation	Zavation	25
Verteloc Spinal System	Signature Orthopaedics PTY Limited	17

Showing 12 of 31. All products under Spinal Vertebral Body Replacement Device – Cervical

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K152568	2016-02-11

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.

Palo Alto ™