Camber Spine Technologies
King of Prussia, PA, US
CAMBER SPINE TECHNOLOGIES appears in FDA device records in King of Prussia, PA. FDA records list 23 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 23 510(k) clearances for Camber Spine Technologies between 2013 and 2024. The busiest year on record is 2017, with 5. The most recent is 2024, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2013 | 1 |
| 2016 | 1 |
| 2017 | 5 |
| 2018 | 4 |
| 2019 | 2 |
| 2020 | 1 |
| 2021 | 1 |
| 2022 | 2 |
| 2023 | 3 |
| 2024 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K234077 | SPIRA® Anterior Lumbar Spacers | MAX | Substantially Equivalent | |
| K232256 | Alcantara Thoracolumbar Plate System | KWQ | Substantially Equivalent | |
| K233972 | Camber Sacroiliac (SI) Fixation System | OUR | Substantially Equivalent | |
| K230942 | SPIRA® Posterior Lumbar Spacers | MAX | Substantially Equivalent | |
| K221324 | ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF) | OVD | Substantially Equivalent | |
| K223837 | SPIRA®-C Integrated Fixation System | OVE | Substantially Equivalent | |
| K203503 | Camber Sacroiliac (SI) Fixation System | OUR | Substantially Equivalent | |
| K220038 | Camber Spine Navigation System | OLO | Substantially Equivalent | |
| K210595 | SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar Spacers | MAX | Substantially Equivalent | |
| K193153 | SPIRA-C Integrated Fixation System | OVE | Substantially Equivalent | |
| K191584 | FORTICO Anterior Cervical Fixation System | KWQ | Substantially Equivalent | |
| K190483 | SPIRA Open Matrix ALIF and LLIF | MAX | Substantially Equivalent | |
| K180980 | ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization System | NKB | Substantially Equivalent | |
| K180724 | SPIRA Open Matrix LLIF | MAX | Substantially Equivalent | |
| K173432 | ENZA-A Titanium ALIF | OVD | Substantially Equivalent | |
| K173800 | Camber Spine Technologies SPIRA - V™ Open Matrix Corpectomy Cage | MQP | Substantially Equivalent | |
| K172446 | SPIRA-C Open Matrix Cervical Interbody | ODP | Substantially Equivalent | |
| K172064 | Ti-Diagon Oblique TLIF | MAX | Substantially Equivalent | |
| K170550 | Coveris Cervical Cage System | ODP | Substantially Equivalent | |
| K162986 | SPIRA Open Matrix ALIF | MAX | Substantially Equivalent | |
| K162121 | Siconus SI Joint Fixation System | OUR | Substantially Equivalent | |
| K153720 | ENZA Zero-Profile Anterior Interbody Fusion | OVD | Substantially Equivalent | |
| K121254 | CAMBER SPINE TECHNOLOGIES TLS 5.0 INERBODY CAGE | MAX | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3010197239 | 3010197239 | CAMBER SPINE TECHNOLOGIES | 501 Allendale Rd, King of Prussia, PA 19406 US | 2026 | and 24 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KWQAppliance, Fixation, Spinal Intervertebral Body
- HWJAwl
- HTWBit, Drill
- KTZCaliper
- KQMCamera, Surgical And Accessories
- FZOChisel, Surgical, Manual
- HTFCurette
- MQVFiller, Bone Void, Calcium Compound
- HTJGauge, Depth
- FZXGuide, Surgical, Instrument
- FZYHammer, Surgical
- ODPIntervertebral Fusion Device With Bone Graft, Cervical
- MAXIntervertebral Fusion Device With Bone Graft, Lumbar
- PHMIntervertebral Fusion Device With Bone Graft, Thoracic
- OVEIntervertebral Fusion Device With Integrated Fixation, Cervical
- OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar
- HXLMallet
- GDMNeedle, Aspiration And Injection, Reusable
- LXHOrthopedic Manual Surgical Instrument
- OLOOrthopedic Stereotaxic Instrument
- MNIOrthosis, Spinal Pedicle Fixation
- MNHOrthosis, Spondylolisthesis Spinal Fixation
- HXBProbe
- HTRRasp
- GADRetractor
- HTXRongeur
- OURSacroiliac Joint Fixation
- HXXScrewdriver
- MQPSpinal Vertebral Body Replacement Device
- FMFSyringe, Piston
- JACSystem, X-Ray, Film Marking, Radiographic
- HXGTamp
- HWXTap, Bone
- NKBThoracolumbosacral Pedicle Screw System
- FSMTray, Surgical, Instrument
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Camber Spine Technologies edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
Data as of , FDA export datePage updated Source: openFDA, public domain