Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2530808

FEI Number

1000522098

Entity Name

Microcision LLC

City/State/Country

Pennsauken, NJ, US

Establishment Address

7115 Airport Hwy, Pennsauken, NJ 08109, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Microcision LLC (Owner Number: 10043166)

Owner / Operator Contact Address

7115 Airport Hwy, Pennsauken, NJ 08109, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Fortico Plate BacFix Ti (Spinal Fixation System) MOTOBAND Arsenal Screw, Fixation Screw Tiger Cannulated Screw System, Tiger Large Cannulated Screw System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2013-02-08
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2013-02-08
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2013-02-08
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2013-02-08
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2013-02-08
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2023-02-07
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2023-02-07
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2021-04-13
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2013-03-26
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2013-03-26
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2020-02-25
KWD	Prosthesis, Toe, Hemi-, Phalangeal	Orthopedic	Class 2	888.3730	2019-01-03
OVE	Intervertebral Fusion Device With Integrated Fixation, Cervical	Orthopedic	Class 2	888.3080	2013-02-08
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2013-02-08
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2013-02-08
NKG	Posterior Cervical Screw System	Orthopedic	Class 2	888.3075	2023-02-24
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2023-02-24
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2017-01-09
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2013-02-08
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2023-03-07
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2017-01-09
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2015-01-26
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2015-01-26
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2015-01-26
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2024-08-02
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2016-02-03
NDN	Cement, Bone, Vertebroplasty	Orthopedic	Class 2	888.3027	2017-01-09
OUR	Sacroiliac Joint Fixation	Orthopedic	Class 2	888.3040	2024-06-27
NDN	Cement, Bone, Vertebroplasty	Orthopedic	Class 2	888.3027	2017-01-09
HWB	Extractor	Orthopedic	Class 1	888.4540	2025-08-29
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2013-02-08
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2021-03-09
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2017-01-09
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2017-01-09
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2024-05-22
PEK	Spinous Process Plate	Orthopedic	Class 2	888.3050	2024-06-27
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2013-02-08
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2013-02-08
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2013-02-08
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2013-02-08
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2013-02-08
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2017-01-09
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2017-01-09
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2020-02-25
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2020-02-25
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2017-01-09
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2013-02-08
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2024-05-22
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2013-01-29
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2013-01-29
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2013-02-08
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2013-02-08
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2013-02-08
HWA	Impactor	Orthopedic	Class 1	888.4540	2025-08-29
MRW	System, Facet Screw Spinal Device	Unknown	Class U	N/A	2013-02-08
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2013-02-08
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2013-02-08

Official Correspondent

Walter Fite Jr

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Microcision LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K192492	Astura Medical, LLC	EL CAPITAN Anterior Lumber Interbody System	2020-04-21
K212498	Nexus Spine, LLC	Stable-L Standalone Lumbar Interbody System	2022-03-18
K223430	Life Spine, Inc.	ProLift Micro Expandable Spacer System	2023-05-04
K102293	Globus Medical, Inc.	CALIBER SPACER	2011-01-05
K193541	Nu Vasive, Incorporated	NuVasive Cohere Thoracolumbar Interbody System	2020-03-30

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0036-2013	Medtronic Sofamor Danek USA Inc	2	ATLANTIS(R) Anterior Cervical Plate System VARIABLE ANGLE SCREW MODULE, REF 176-503, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used.
Z-0037-2013	Medtronic Sofamor Danek USA Inc	2	ATLANTIS(R) Anterior Cervical Plate System FIXED ANGLE SCREW MODULE, REF 176-504, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used.
Z-0038-2013	Medtronic Sofamor Danek USA Inc	2	PREMIER(R) Anterior Cervical Plate System SCREW BLOCK, REF 1860503, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used.
Z-0040-05	Zimmer Spine, Inc.	2	ATO Drill Guide Kit (All Through One Drill Guides Set), model number 07.00860.001, product is packaged in trays.
Z-0014-2014	Synthes USA HQ, Inc.	2	Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions, and fusions of large bones in the foot and ankle.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2530808. Last updated year: 2026. Please use registration number 2530808 when referencing this establishment in official correspondence.