Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
Osteotech, Inc. — Predicate Candidate Screening
24 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
90 daysmedian FDA review time
381 days90th percentile
24clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K082615 | GRAFTON R II EDBM, DEMINERALIZED BONE MATRIX ALLOGRAFT, RESO | Osteotech, Inc. | 2008-10-16 | 37 | 1 |
| K081227 | PLEXUR M | Osteotech, Inc. | 2008-07-22 | 83 | 0 |
| K080511 | PLEXUR-P | Osteotech, Inc. | 2008-04-21 | 56 | 0 |
| K073405 | PLEXUR M | Osteotech, Inc. | 2008-03-03 | 90 | 0 |
| K061982 | PLEXUR P | Osteotech, Inc. | 2007-02-07 | 209 | 0 |
| K051188 | GRAFTON DBM | Osteotech, Inc. | 2006-01-03 | 238 | 13 |
| K051781 | GRAFTCAGE TLX | Osteotech, Inc. | 2005-12-16 | 168 | 1 |
| K051195 | GRAFTON DBM | Osteotech, Inc. | 2005-12-16 | 220 | 29 |
| K043209 | VIAGRAF DBM PASTE | Osteotech, Inc. | 2005-12-05 | 381 | 0 |
| K053080 | GRAFTCAGE ACX | Osteotech, Inc. | 2005-12-01 | 29 | 0 |
| K042707 | GRAFTON PLUS DBM PASTE | Osteotech, Inc. | 2005-11-30 | 426 | 12 |
| K043048 | GRAFTON PLUS DBM PASTE | Osteotech, Inc. | 2005-11-23 | 384 | 14 |
| K012254 | VBR | Osteotech, Inc. | 2001-10-16 | 90 | 0 |
| K003155 | VERTEBRAL BODY REPLACEMENT | Osteotech, Inc. | 2001-01-04 | 86 | 0 |
| K003384 | VERSALINK TITANIUM ROD-TO-ROD COUPLERS | Osteotech, Inc. | 2000-11-24 | 24 | 0 |
| K992885 | VERSALOK LOW BACK FIXATION SYSTEM | Osteotech, Inc. | 1999-11-19 | 84 | 0 |
| K991586 | SSCS (SEGMENTAL SPINAL CORRECTION SYSTEM) | Osteotech, Inc. | 1999-07-23 | 77 | 0 |
| K973868 | SSCS (SEGMENTAL SPINAL CORRECTION SYSTEM) | Osteotech, Inc. | 1998-01-08 | 90 | 0 |
| K971289 | SSCS (SEGMENTAL SPINAL CORRECTION SYSTEM) | Osteotech, Inc. | 1997-06-18 | 72 | 0 |
| K955173 | SSCS (SEGMENTAL SPINAL CORRECTION SYSTEM) | Osteotech, Inc. | 1996-02-09 | 88 | 0 |
| K950652 | OSTEOTECH NAVICULAR AND CANCELLOUS CANNULATED SCREWS | Osteotech, Inc. | 1995-06-22 | 129 | 0 |
| K951811 | OSTEOTECH MUSCULOSKELETAL TISSUE RECOVERY PACK | Osteotech, Inc. | 1995-05-31 | 42 | 0 |
| K883065 | ALLOPREP SYSTEM | Osteotech, Inc. | 1988-10-13 | 85 | 0 |
| K852199 | OSTEOGRAF 2040 OSTEOGRAF 4060 | Osteotech, Inc. | 1985-10-07 | 140 | 0 |
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