Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Interpore Cross Intl. — Predicate Candidate Screening
39 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
52 daysmedian FDA review time
216 days90th percentile
39clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K050861 | PEEK CAS | Interpore Cross Intl. | 2005-05-27 | 52 | 0 |
| K031399 | INTERGRO DBM | Interpore Cross Intl. | 2005-02-18 | 655 | 1 |
| K041407 | TITANIUM MESH IMPLANT | Interpore Cross Intl. | 2004-12-29 | 216 | 0 |
| K043229 | MODIFICATION TO ALTIUS OCT SYSTEM | Interpore Cross Intl. | 2004-12-21 | 29 | 0 |
| K042798 | C-TEK C-TRUN ANTERIOR CERVICAL PLATE SYSTEM | Interpore Cross Intl. | 2004-11-04 | 27 | 0 |
| K040928 | EXPANDABLE PEEK VBR IMPLANT | Interpore Cross Intl. | 2004-08-27 | 140 | 0 |
| K041794 | C-TEK C-THRU ANTERIOR CERVICAL PLATE SYSTEM | Interpore Cross Intl. | 2004-07-19 | 17 | 0 |
| K041449 | SYNERGY HELICAL FLANGE PLUG, HELICAL FLANGE SEAT AND HELICAL | Interpore Cross Intl. | 2004-07-01 | 30 | 0 |
| K033961 | ALTIUS OCT SYSTEM | Interpore Cross Intl. | 2004-04-14 | 114 | 0 |
| K040168 | MODIFICATION TO GEO STRUCTURE | Interpore Cross Intl. | 2004-04-08 | 73 | 1 |
| K031772 | TI FENESTRATED PLATE | Interpore Cross Intl. | 2003-09-05 | 88 | 0 |
| K032095 | INTERPORE CROSS CEMENT RESTRICTOR | Interpore Cross Intl. | 2003-08-08 | 31 | 0 |
| K023908 | INTERPORE CROSS CEMENT RESTRICTOR | Interpore Cross Intl. | 2003-05-16 | 172 | 0 |
| K022143 | INTERPORE CROSS INTERNATIONAL ANTERIOR FIXATION DEVICE (AFD) | Interpore Cross Intl. | 2003-01-23 | 205 | 0 |
| K022048 | INTERPORE CROSS INTERNATIONAL (ICI) OCCIPITO-CERVICO-THORACI | Interpore Cross Intl. | 2002-12-04 | 163 | 0 |
| K022348 | ACCESS CONCENTRATION SYSTEM, MODEL ACC-100, ACCESS DISPOSABL | Interpore Cross Intl. | 2002-08-15 | 27 | 0 |
| K012406 | ACCESS SEQUESTRATION SYSTEM | Interpore Cross Intl. | 2002-03-26 | 239 | 0 |
| K020204 | TELESCOPIC PLATE SPACER THORACOLUMBAR (TPS-TL) SPINAL SYSTEM | Interpore Cross Intl. | 2002-02-21 | 30 | 0 |
| K020048 | MODIFICATION TO GEO STRUCTURE | Interpore Cross Intl. | 2002-02-06 | 30 | 0 |
| K014145 | MODIFICATION TO TELESCOPIC PLATE SPACER THORACOLUMBAR (TPS-T | Interpore Cross Intl. | 2002-01-17 | 30 | 0 |
| K010989 | TELESCOPIC PLATE SPACER THORACOLUMBAR (TPS-TL) SPINAL, MODEL | Interpore Cross Intl. | 2001-11-07 | 218 | 0 |
| K012871 | SYNERGY TI INTEGRAL OPEN SCREWS MODELS # 6193, 6194, 6195,61 | Interpore Cross Intl. | 2001-09-13 | 17 | 0 |
| K010530 | GEO STRUCTURE | Interpore Cross Intl. | 2001-08-03 | 161 | 0 |
| K004003 | PRO OSTEON 200R WITH CALCIUM SULFATE, MODELS 2RCS038, 2RCS05 | Interpore Cross Intl. | 2001-07-19 | 206 | 0 |
| K011148 | ULTRACONCENTRATOR SYSTEM | Interpore Cross Intl. | 2001-06-13 | 58 | 0 |
| K011437 | SYNERGY 4.0 MM, 4.5 MM VLS SCREWS | Interpore Cross Intl. | 2001-06-06 | 27 | 0 |
| K010708 | APPLICATOR TIP/DUAL SPRAYER KIT | Interpore Cross Intl. | 2001-04-30 | 52 | 0 |
| K010515 | MODIFICATION TO SYNERGY SPINAL SYSTEM | Interpore Cross Intl. | 2001-03-22 | 28 | 0 |
| K002592 | INTERPORE CROSS ANTERIOR CERVICAL PLATE SYSTEM | Interpore Cross Intl. | 2000-10-06 | 46 | 0 |
| K000515 | PRO OSTEON 200R RESORBABLE BONE GRAFT SUBSTITUTE, MODELS 2RG | Interpore Cross Intl. | 2000-09-15 | 212 | 0 |
| K000876 | SYNERGY ADJUSTABLE TRANSVERSE CONNECTOR ROD, SYNERGY ADJUSTA | Interpore Cross Intl. | 2000-04-18 | 29 | 0 |
| K000236 | SYNERGY VLS CAP NUT MODELS 2206, 6102 | Interpore Cross Intl. | 2000-02-16 | 20 | 0 |
| K993808 | SYNERGY INTEGRAL SCREWS, MODEL NUMBERS 2161,2162,2163,2164,2 | Interpore Cross Intl. | 1999-12-06 | 26 | 0 |
| K992369 | SYNERGY INTEGRAL SCREWS, MODELS, 2161,2162,2163,2164,2165,21 | Interpore Cross Intl. | 1999-10-13 | 90 | 0 |
| K991854 | OSTEOPLAST, MODEL POP200 | Interpore Cross Intl. | 1999-08-26 | 86 | 0 |
| K990057 | SYNERGY ADJUSTABLE LENGTH ROD | Interpore Cross Intl. | 1999-06-28 | 172 | 0 |
| K984578 | SYNERGY D2 SPINAL IMPLANTS | Interpore Cross Intl. | 1999-03-23 | 90 | 0 |
| K990131 | PRO OSTEON IMPLANT 500R RESORBABLE BONE GRAFT SUBSTITUTE | Interpore Cross Intl. | 1999-03-02 | 47 | 0 |
| K982368 | MANIFOLD WITH EXTENSION SET | Interpore Cross Intl. | 1998-07-31 | 24 | 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