Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Danek Medical, Inc. · Predicate Candidate Screening
56 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
90 daysmedian FDA review time
387 days90th percentile
56clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K994122 | BONE GRAFT WASHER, MODEL 9090114 - 9090118 | Danek Medical, Inc. | 2000-02-18 | 73 | 0 |
| K993810 | CD HORIZON SPINAL SYSTEM | Danek Medical, Inc. | 2000-02-03 | 85 | 0 |
| K993855 | ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM | Danek Medical, Inc. | 1999-12-15 | 30 | 0 |
| K991528 | MODIFICATION TO TENOR SPINAL SYSTEM-ROD/BOLT CONNECTOR | Danek Medical, Inc. | 1999-05-28 | 25 | 0 |
| K990603 | MODIFICATION OF THE ZPLATE-ATL ANTERIOR FIXATION SYSTEM | Danek Medical, Inc. | 1999-03-10 | 15 | 0 |
| K982875 | MODIFICATION TO ZPLATE-ATL ANTERIOR FIXATION SYSTEM | Danek Medical, Inc. | 1999-01-19 | 158 | 0 |
| K984522 | MODIFICATION OF TSRH SPINAL SYSTEM | Danek Medical, Inc. | 1999-01-06 | 16 | 1 |
| K982154 | MODIFICATION OF TOWNLEY PEDICLE SCREW PLATING SYSTEM | Danek Medical, Inc. | 1998-07-13 | 24 | 0 |
| K970599 | TOWNLEY PEDICLE SCREW PLATING SYSTEM | Danek Medical, Inc. | 1998-03-20 | 395 | 0 |
| K943827 | SPINE FIXATION | Danek Medical, Inc. | 1996-02-14 | 558 | 0 |
| K943356 | INCLUSIVE ENDOSCOPE | Danek Medical, Inc. | 1995-05-10 | 302 | 0 |
| K943676 | DANEKSCOPE OPTI-PROBE | Danek Medical, Inc. | 1994-11-21 | 118 | 0 |
| K933205 | TSRH(R) TOP TIGHT T-BOLT-VARI ANGLE/SCREW/PARAGON | Danek Medical, Inc. | 1994-05-04 | 307 | 0 |
| K933242 | SOFAMOR ORTHOPAEDIC INSTRUMENTS | Danek Medical, Inc. | 1994-01-28 | 210 | 0 |
| K911729 | DANEKSCOPE AND ACCESSORIES | Danek Medical, Inc. | 1993-04-05 | 719 | 0 |
| K901692 | DANEK SPINALSCOPE | Danek Medical, Inc. | 1992-02-14 | 674 | 0 |
| K904243 | TSRH VARIABLE ANGLE SACRAL SCREW | Danek Medical, Inc. | 1992-01-22 | 495 | 0 |
| K913735 | SONGER(TM) CABLE SYSTEM | Danek Medical, Inc. | 1991-11-18 | 90 | 0 |
| K904520 | RAY SACRAL FIXATION SYSTEM | Danek Medical, Inc. | 1991-10-25 | 387 | 0 |
| K911307 | CROSSLINK PLATE | Danek Medical, Inc. | 1991-10-24 | 213 | 0 |
| K911379 | DANEK SACRAL HOOK, MODIFICATION | Danek Medical, Inc. | 1991-09-11 | 168 | 0 |
| K911306 | T-BOLT AND NUT | Danek Medical, Inc. | 1991-09-10 | 169 | 0 |
| K911319 | TSRH OPEN HEAD BONE SCREW | Danek Medical, Inc. | 1991-09-06 | 164 | 0 |
| K911300 | MICROSURGICAL INSTRUMENTS | Danek Medical, Inc. | 1991-04-05 | 11 | 0 |
| K902775 | KNIGHT SACRAL SCREW | Danek Medical, Inc. | 1990-12-10 | 168 | 0 |
| K901005 | TSRH SPINAL SYSTEM (ADD'L SIZES OF HOOKS) | Danek Medical, Inc. | 1990-12-10 | 283 | 0 |
| K903461 | TSRH OFFSET AND SIDE-LOADING HOOKS | Danek Medical, Inc. | 1990-12-05 | 126 | 0 |
| K901587 | TSRH SACRAL L-CONNECTOR | Danek Medical, Inc. | 1990-11-05 | 215 | 0 |
| K903676 | STERNOTOMY CABLE, SONGER CABLE SYSTEM | Danek Medical, Inc. | 1990-09-10 | 28 | 0 |
| K903105 | OLIVE K-WIRES | Danek Medical, Inc. | 1990-09-06 | 63 | 0 |
| K901590 | DANEK SACRAL HOOK | Danek Medical, Inc. | 1990-08-21 | 138 | 0 |
| K895978 | CHIBA SPINAL SYSTEM | Danek Medical, Inc. | 1990-08-09 | 301 | 0 |
| K896254 | DANEK PRECISION ROD SET | Danek Medical, Inc. | 1990-06-14 | 227 | 0 |
| K896740 | AXIAL AND OFFSET CROSSLINK PLATES | Danek Medical, Inc. | 1990-02-26 | 88 | 0 |
| K896603 | HSC UNIT ROD | Danek Medical, Inc. | 1990-01-30 | 70 | 0 |
| K890192 | LUQUE III SPINAL SYSTEM AND LUQUE MINI-SET | Danek Medical, Inc. | 1990-01-04 | 351 | 0 |
| K891066 | DANEK WRIST FIXATOR | Danek Medical, Inc. | 1989-08-28 | 180 | 0 |
| K892651 | SONGER WIRING SYSTEM | Danek Medical, Inc. | 1989-07-25 | 103 | 0 |
| K890814 | DANEK RING FIXATOR (DRF) | Danek Medical, Inc. | 1989-06-13 | 117 | 0 |
| K890090 | DANEK IRRIGATING BURR (DIB) SET | Danek Medical, Inc. | 1989-01-24 | 14 | 0 |
| K843227 | MACULAR FUNCTION ANALYZER | Danek Medical, Inc. | 1985-07-22 | 340 | 0 |
| K823821 | SIDE RAIL PADS | Danek Medical, Inc. | 1983-01-21 | 35 | 0 |
| K823808 | VARIOUS ARM SLING | Danek Medical, Inc. | 1983-01-14 | 28 | 0 |
| K823810 | A.C. SPLINT | Danek Medical, Inc. | 1983-01-14 | 28 | 0 |
| K823812 | VARIOUS SUPPORTS AND SPLINTS | Danek Medical, Inc. | 1983-01-14 | 28 | 0 |
| K823823 | LUMBOSACRAL SUPPORT | Danek Medical, Inc. | 1983-01-14 | 28 | 0 |
| K823816 | WHEELCHAIR PATIENT RESTRAINTS | Danek Medical, Inc. | 1983-01-14 | 28 | 0 |
| K823811 | OVERHEAD ARM SLINGS | Danek Medical, Inc. | 1983-01-14 | 28 | 0 |
| K823814 | HOT/COLD PACK HOLDERS | Danek Medical, Inc. | 1983-01-14 | 28 | 0 |
| K823813 | TRACTION ACCESSORIES | Danek Medical, Inc. | 1983-01-14 | 28 | 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