FDA Registration Active 🇺🇸 United States

RENOVIS S134 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM

Reg #: 3015398319 · FEI: 3007932279 · Expires 2025
Products
2
Proprietary Names
1
Establishment Types
2
Classifications
2

Registration Details

Registration Name
Kyocera Medical Technologies, Inc.
Registration Number
3015398319
FEI Number
3007932279
Status
Active
Expiry Year
2025
Initial Importer
Yes
Address
1289 Bryn Mawr Ave Ste A
City
Redlands
State
CA
ZIP
92374
Country
US

Regulatory Submissions

510(k) Number
K142095

Owner / Operator

Firm Name
Kyocera Medical Technologies, Inc.
Operator Number
10030880
Address
1289 Bryn Mawr Avenue, Suite A
City
Redlands
State
CA
Postal Code
92374
Country
US
Correspondent
Anthony DeBenedictis

Products

Device Name Product Code
Intervertebral Fusion Device With Integrated Fixation, Lumbar OVD
Intervertebral Fusion Device With Bone Graft, Lumbar MAX

Proprietary Names

RENOVIS S134 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM

Establishment Types

Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198