Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010197239

FEI Number

3010197239

Entity Name

CAMBER SPINE TECHNOLOGIES

City/State/Country

King of Prussia, PA, US

Establishment Address

501 Allendale Rd, King of Prussia, PA 19406, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Repack or Relabel Medical Device,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Camber Spine/Medical Technologies (Owner Number: 10043961)

Owner / Operator Contact Address

501 Allendale Rd., King of Prussia, PA 19406, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Rasp SPIRA®-L Open Matrix LLIF Bone Tap Awl SPIRA Open Matrix ALIF Pinnacle Lateral Implants Probe Rongeur ALTIVO Anterior Cervical Fixation System Aspiration needle SPIRA-O Open Matrix OLIF Surgical Hammer INFILL Graft Delivery System Pinnacle Lateral Implants Diagon Oblique Cage Caliper Camber Spine Navigation System OLIF Retractor Light Source Scylla OLIF Retractor Articulating Inserter Handle, Lateral OLIF Retractor Articulating Inserter Handle OLIF Retractor Articulating Handle Hex Shaft OLIF Retractor Articulating Inserter Slap Hammer Cap Pinnacle Lateral Implants OLIF Disc Marking Tool Spira-TA Enza-A Titanium ALIF OLIF Disc Prep Tray #1 OLIF Retractor, Blade Tray #3 PSG 5.5mm Cannulated Pedicle Screw System Ti-Diagon Oblique TLIF Chisel Mallet SPIRA-C Open Matrix Cervical Interbody Spira-P Posterior Lumbar Spacer Spira-T Inserter Spira-T Posterior Lumbar Spacer Spira-P Inserter Verta Corpectomy Cage Orthros MIS Coveris Cage Pinnacle Lateral Implants Alcantara Thoracolumbar Plate System Spira Anterior Lumbar Spacers SPIRA-V Open Matrix Corpectomy Cage Spira-C MANUS Carpal Ligament Knife Bone Buddies Bone Harvester

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HTR	Rasp	General, Plastic Surgery	Class 1	878.4800	2021-07-11
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2020-02-17
HWX	Tap, Bone	Orthopedic	Class 1	888.4540	2021-07-11
HWJ	Awl	Orthopedic	Class 1	888.4540	2021-07-11
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2017-06-15
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2022-04-08
HXB	Probe	Orthopedic	Class 1	888.4540	2021-07-11
HTX	Rongeur	Orthopedic	Class 1	888.4540	2021-07-11
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2020-02-17
GDM	Needle, Aspiration And Injection, Reusable	General, Plastic Surgery	Class 1	878.4800	2021-07-11
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2020-11-11
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2020-11-11
FZY	Hammer, Surgical	General, Plastic Surgery	Class 1	878.4800	2021-07-11
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2022-04-08
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2022-04-08
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2017-05-02
KTZ	Caliper	Orthopedic	Class 1	888.4150	2021-07-11
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2022-09-13
KQM	Camera, Surgical And Accessories	General, Plastic Surgery	Class 1	878.4160	2021-01-08
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2020-11-11
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2021-02-26
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2022-04-08
JAC	System, X-Ray, Film Marking, Radiographic	Radiology	Class 1	892.1640	2021-10-19
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2024-02-21
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2019-02-04
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2021-02-26
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2022-04-08
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2022-04-08
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2022-04-08
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2018-04-17
FZO	Chisel, Surgical, Manual	General, Plastic Surgery	Class 1	878.4800	2021-07-11
HXL	Mallet	General, Plastic Surgery	Class 1	878.4800	2021-07-11
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2018-01-09
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2021-07-12
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2016-09-15
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2019-01-24
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2017-05-02
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2022-04-08
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2024-05-02
OVE	Intervertebral Fusion Device With Integrated Fixation, Cervical	Orthopedic	Class 2	888.3080	2020-05-12
PHM	Intervertebral Fusion Device With Bone Graft, Thoracic	Orthopedic	Class 2	888.3080	2024-09-09
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2024-09-09
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2024-09-09
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2018-07-25
OVE	Intervertebral Fusion Device With Integrated Fixation, Cervical	Orthopedic	Class 2	888.3080	2024-02-21
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2013-07-25

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Camber Spine/Medical Technologies

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-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-0003-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 30G X 5/16'' syringes

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010197239. Last updated year: 2026. Please use registration number 3010197239 when referencing this establishment in official correspondence.