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

Innovative Spinal Technologies, Inc. — Predicate Candidate Screening

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

K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K072650IST ANTERIOR CERVICAL PLATE SYSTEMInnovative Spinal Technologies, Inc.2007-11-28700
K072120PARAMOUNT INTERVERTEBRAL BODY FUSION DEVICEInnovative Spinal Technologies, Inc.2007-10-11710
K062759PARAMOUNT VBR SYSTEMInnovative Spinal Technologies, Inc.2007-01-121190
K053276IST PEDICLE SCREW SYSTEMInnovative Spinal Technologies, Inc.2005-12-27340

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