Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015991317

FEI Number

3015991317

Entity Name

ELEVATION SPINE

City/State/Country

Monterey, CA, US

Establishment Address

2511 Garden Road, Suite B125, Monterey, CA 93940, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Elevation Spine (Owner Number: 10061171)

Owner / Operator Contact Address

2511 Garden Road, Suite B125, Monterey, CA 93940, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Trial Head 14x17x5 9 deg. Trial Head 15x18x6 0 deg. Trial Head 14x17x7 6 deg. Trial Head 15x18x5 6 deg. Trial Head 14x15x6 9 deg. Trial Head 14x17x8 9 deg. Trial Head 12x15x7 6 deg. Trial Head 14x17x6 0 deg. Trial Head 15x18x7 0 deg. Trial Head 12x15x6 9 deg. Trial Head 15x18x10 0 deg. Trial Head 14x17x10 0 deg. Trial Head 12x15x10 0 deg. Trial Head 15x18x7 6 deg. Trial Head 15x18x10 9 deg. Trial Head 14x15x10 9 deg. Trial Head 14x15x9 0 deg. Trial Head 14x17x7 0 deg. Trial Head 15x18x9 9 deg. Trial Head 14x15x10 6 deg. Trial Head 14x15x10 0 deg. Trial Head 14x17x9 6 deg. Trial Head 14x17x8 6 deg. Trial Head 12x15x6 0 deg. Trial Head 12x15x10 6 deg. Trial Head 12x15x6 6 deg. Trial Head 15x18x8 6 deg. Trial Head 15x18x10 6 deg. Trial Head 14x17x6 9 deg. Trial Head 12x15x8 6 deg. Trial Head 14x15x6 0 deg. Trial Head 15x18x5 0 deg. Trial Head 15x18x8 9 deg. Trial Handle Trial Head 12x15x9 6 deg. Trial Head 14x17x8 0 deg. Trial Head 14x15x8 9 deg. Trial Head 14x17x6 6 deg. Trial Head 14x17x10 9 deg. Trial Head 14x15x9 9 deg. Trial Head 14x15x6 6 deg. Trial Head 14x17x5 0 deg. Trial Head 15x18x7 9 deg. Trial Head 12x15x8 9 deg. Trial Head 15x18x6 6 deg. Trial Head 15x18x9 6 deg. Trial Head 15x18x8 0 deg. Trial Head 12x15x5 9 deg. Trial Head 12x15x9 9 deg. Trial Head 12x15x7 0 deg. Trial Head 14x15x7 6 deg. Trial Head 15x18x9 0 deg. Trial Head 14x17x9 9 deg. Trial Head 14x15x9 6 deg. Trial Head 14x17x5 6 deg. Trial Head 14x15x5 6 deg. Trial Head 14x17x9 0 deg. Trial Head 12x15x5 6 deg. Trial Head 14x15x8 6 deg. Trial Head 14x15x5 0 deg. Trial Head 14x15x8 0 deg. Trial Head 14x17x10 6 deg. Trial Head 15x18x5 9 deg. Trial Head 12x15x8 0 deg. Trial Head 14x15x5 9 deg. Trial Head 14x15x7 9 deg. Trial Head 12x15x5 0 deg. Trial Head 12x15x9 0 deg. Trial Head 15x18x6 9 deg. Trial Head 14x17x7 9 deg. Trial Head 14x15x7 0 deg. Trial Head 12x15x10 9 deg. Trial Head 12x15x7 9 deg. TRAY RASP Screw Handle Saber-C System Awl, Straight Handle (Awl, Drill) Spike Driver (Final) Spike Driver, 8-9mm Assembly tool Inserter Spike Driver Spike Extractor Carriage 9mm Locking Plate Inserter Guide, 10mm Carriage 5-6mm Spike Driver, 10mm Spike Removal Tool Carriage 10mm Carriage 8mm Carriage 7mm Guide, 7mm Guide, 8mm Spike Driver, 5-7mm Guide, 9mm Guide, 5-6mm Drill, Straight

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HWT	Template	Orthopedic	Class 1	888.4800	2022-12-14
LRP	Tray, Surgical	General, Plastic Surgery	Class 1	878.4800	2024-01-17
HTR	Rasp	General, Plastic Surgery	Class 1	878.4800	2024-01-17
HXC	Wrench	Orthopedic	Class 1	888.4540	2022-12-14
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2019-09-04
OVE	Intervertebral Fusion Device With Integrated Fixation, Cervical	Orthopedic	Class 2	888.3080	2019-09-04
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2019-09-04
HWJ	Awl	Orthopedic	Class 1	888.4540	2022-12-14
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2022-12-14
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2022-12-14

Official Correspondent

Christine Scifert

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Elevation Spine

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
K881095	CooperVision, Inc.	KOI(TM) INSTRUMENT TRAYS	1988-04-06
K032752	R&B Surgical Solutions, LLC	R&B SURGICAL SMARTPLATE CERVICAL PLATE SYSTEM	2003-12-03
K062643	Life Spine	KINETIC ANTERIOR CERVICAL PLATE	2006-11-16
K142269	Reliance Medical Systems, LLC	Reliance Cervical IBF System	2015-06-09
K122085	Omni Surgical, LP Dba Spine360	STINGRAY CERVICAL CAGE	2012-10-17

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0036-2010	Alphatec Spine, Inc.	1	ROC Lumbar bolt caddy, Part Number: 81997-01-05. Sterilization container for ROC bolts/screws. Product is used to contain spinal implants.
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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015991317. Last updated year: 2026. Please use registration number 3015991317 when referencing this establishment in official correspondence.