Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007279845

FEI Number

3007279845

Entity Name

CALVARY SPINE, LLC

City/State/Country

Towson, MD, US

Establishment Address

308 North Wind Rd., Towson, MD 21204, US

Establishment Type(s)

Repack or Relabel Medical Device,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Calvary Spine, LLC (Owner Number: 10027607)

Owner / Operator Contact Address

308 North Wind Rd., Towson, MD 21204, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Calvary Lumbar Interbody Spacers/ Fusion Device (crescent & straight-shaped interbody cages; 7-15mm heights) Calvary Cervical Interbody Spacers/ Fusion Device (standard & large footprint interbody cages; 5-9mm heights) Extra Small, Small, Medium, and Large Variable Crosslinks Pre Lordosed Rod 5.5mm Diameter 30mm - 100mm lengths made from Ti6Al4V, CP Titanium, or CoCr Calvary Spine Pedicle Screw System Polyaxial Screw, Reduction Screws, & Cannulated Polyaxial Screws: 5.5mm, 6.5mm, 7.5mm, & 8.5mm dia in 25-90mm length Iliac Connector 5.5mm Diameter 30mm & 50 mm rod lengths Locking cap for Polyaxial screws Straight Rod 5.5mm Diameter 240mm or 480mm lengths made from Ti6Al4V, CP Titanium, or CoCr 23mm, 24mm, 25mm, 26mm, 27mm, 28mm Fixed Crosslinks Cervical Instruments: 5-9mm trials, 5-9mm dual head trials, rasp, tamp, mallet, inserter, caddy, instrument tray & lid Lumbar Instruments: 6mm distractor, 7-15mm shaver, caddy, tray & lid Lumbar Instruments: 7-15mm straight & crescent trials, implant inserter with locking rod, cup & uterine curettes

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2008-11-19
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2008-11-19
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2020-11-23
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2011-10-06

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Calvary Spine, 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
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
K080401	Advanced Medical Technologies AG	SHELL CAGE, WAVE CAGE, LOOP CAGE	2008-05-09
K200084	Zavation Medical Products, LLC	Zavation IBF System	2020-10-19

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2013	Synthes USA HQ, Inc.	2	MIRS for MATRIX Spine System. Minimally Invasive Reduction Screw (MIRS) for percutaneous instrumentation of the thoracolumbar spine. The Synthes USS are non-cervial spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5).
Z-0004-2008	Abbott Spine	2	PathFinder Bone Drill-Awl-Tap, a part of the PathFinder spinal stablization system, Part Number 1156-50.
Z-0005-2008	Abbott Spine	2	PathFinder Bone Drill-Awl-Tap, a part of the PathFinder spinal stabilization system, Part Number 1156-60.
Z-0020-06	Pioneer Surgical Technology	2	Pioneer Surgical brand Quantum Spinal Rod System Polyaxial Screw, length 45 mm; Catalog number 10-575-PA-45.
Z-0021-06	Pioneer Surgical Technology	2	Pioneer Surgical brand Quantum Spinal Rod System Polyaxial Screw, length 40 mm; Catalog number 10-575-PA-40.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007279845. Last updated year: 2026. Please use registration number 3007279845 when referencing this establishment in official correspondence.