Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Camber Spine Technologies — Predicate Candidate Screening

17 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

139 daysmedian FDA review time
261 days90th percentile
17clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies2024-07-122030
K233972Camber Sacroiliac (SI) Fixation SystemCamber Spine Technologies2024-02-27740
K230942SPIRA® Posterior Lumbar SpacersCamber Spine Technologies2023-07-11990
K221324ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALCamber Spine Technologies2023-03-303280
K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies2023-03-22900
K220038Camber Spine Navigation SystemCamber Spine Technologies2022-04-291140
K193153SPIRA-C Integrated Fixation SystemCamber Spine Technologies2020-04-241630
K190483SPIRA Open Matrix ALIF and LLIFCamber Spine Technologies2019-09-232080
K173432ENZA-A Titanium ALIFCamber Spine Technologies2018-04-181670
K173800Camber Spine Technologies SPIRA - V™ Open Matrix Corpectomy Camber Spine Technologies2018-02-02500
K172446SPIRA-C Open Matrix Cervical InterbodyCamber Spine Technologies2017-11-07850
K172064Ti-Diagon Oblique TLIFCamber Spine Technologies2017-09-15700
K170550Coveris Cervical Cage SystemCamber Spine Technologies2017-07-131390
K162986SPIRA Open Matrix ALIFCamber Spine Technologies2017-06-122280
K162121Siconus SI Joint Fixation SystemCamber Spine Technologies2017-01-181700
K153720ENZA Zero-Profile Anterior Interbody FusionCamber Spine Technologies2016-05-031270
K121254CAMBER SPINE TECHNOLOGIES TLS 5.0 INERBODY CAGECamber Spine Technologies2013-01-112610

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda