Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Linvatec Corp. — Predicate Candidate Screening
93 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
88 daysmedian FDA review time
265 days90th percentile
93clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K092998 | CONMED LINVATEC INTERCEPT IMPLANT | Linvatec Corp. | 2009-12-23 | 86 | 0 |
| K091549 | CONMED LINVATEC SOFT TISSUE TO BONE SYSTEM | Linvatec Corp. | 2009-06-23 | 27 | 0 |
| K090835 | CONMED LINVATEC BIO MINI-REVO SUTURE ANCHOR, MODEL C6170CR | Linvatec Corp. | 2009-06-22 | 87 | 0 |
| K090186 | CONMED LINVATEC PALADIN, PRELOADED WITH TWO #2 HI-FI SUTURES | Linvatec Corp. | 2009-04-10 | 74 | 0 |
| K083281 | EL LIGHTWAVE SUCTION ABLATOR, MODEL EL-2000-S, LIGHTWAVE SUC | Linvatec Corp. | 2009-02-25 | 110 | 0 |
| K060198 | MICROPOWER HAND PIECE : MEDIUM SPEED DRILL, SAGGITAL SAW, RE | Linvatec Corp. | 2006-05-11 | 105 | 0 |
| K060260 | MICROPOWER HAND PIECE HIGH SPEED DRILL | Linvatec Corp. | 2006-04-10 | 68 | 0 |
| K060270 | MICROPOWER HAND PIECE: ORAL MAX HIGH SPEED DRILL | Linvatec Corp. | 2006-04-10 | 68 | 0 |
| K050519 | ADVANCED TURBO DRIVE SYSTEM | Linvatec Corp. | 2005-05-17 | 77 | 2 |
| K050497 | BIOSCREW XTRALOK, 8X35MM & 8X40MM VIOLET | Linvatec Corp. | 2005-03-25 | 25 | 0 |
| K050227 | THREVO SUTURE ANCHOR WITH DISPOSABLE DRIVER | Linvatec Corp. | 2005-03-02 | 29 | 0 |
| K043106 | PINN-ACL CROSSPIN | Linvatec Corp. | 2005-01-19 | 71 | 0 |
| K042778 | BIOANCHOR WITH DISPOSABLE DRIVER, PRELOADED WITH ONE #2 HERC | Linvatec Corp. | 2004-11-04 | 29 | 1 |
| K041128 | SUTURE ARROW | Linvatec Corp. | 2004-07-29 | 90 | 0 |
| K041713 | SUPER REVO HERCULINE SUTURE ANCHOR | Linvatec Corp. | 2004-07-22 | 29 | 0 |
| K033573 | LINVATEC 10K IRRIGATION SYSTEM | Linvatec Corp. | 2004-02-11 | 90 | 0 |
| K033804 | BIOANCHOR WITH DISPOSABLE DRIVER | Linvatec Corp. | 2003-12-31 | 23 | 1 |
| K033748 | TRIDENT RESECTION ABLATOR | Linvatec Corp. | 2003-12-15 | 14 | 0 |
| K032607 | POWERPRO PNEUMATIC SYSTEM, MODELS PRO6150, PRO6175, PRO6185 | Linvatec Corp. | 2003-11-10 | 77 | 0 |
| K031994 | LINVATEC 300W XENON LIGHT SOURCE | Linvatec Corp. | 2003-08-21 | 55 | 1 |
| K031098 | 3-CCD DIGITAL CAMERA SYSTEM | Linvatec Corp. | 2003-06-04 | 58 | 0 |
| K030720 | ULTRABLATOR ELECTRODE | Linvatec Corp. | 2003-06-03 | 88 | 0 |
| K022827 | ULTRAFIX KNOTLESS MINIMITE SUTURE ANCHOR | Linvatec Corp. | 2002-11-22 | 88 | 0 |
| K013131 | BIOSCREW XTRALOK | Linvatec Corp. | 2002-06-11 | 265 | 1 |
| K020377 | PRE-LOADED BIOSTINGER HORNET | Linvatec Corp. | 2002-05-06 | 90 | 1 |
| K013369 | RESECTION ABLATOR | Linvatec Corp. | 2002-04-04 | 175 | 0 |
| K013553 | PRE-LOADED ULTRAFIX RC | Linvatec Corp. | 2001-12-19 | 55 | 0 |
| K013117 | RESECTION ABLATOR | Linvatec Corp. | 2001-11-29 | 72 | 0 |
| K012320 | POWERPRO BATTERY SYSTEM | Linvatec Corp. | 2001-10-19 | 88 | 0 |
| K003984 | SUPER REVO SUTURE ANCHOR | Linvatec Corp. | 2001-03-19 | 83 | 0 |
| K002088 | SHAVER ABLATOR | Linvatec Corp. | 2001-03-06 | 238 | 0 |
| K002523 | ADVANTAGE DRIVE SYSTEM | Linvatec Corp. | 2000-10-06 | 52 | 0 |
| K993885 | ULTRABLATOR ELECTRODE | Linvatec Corp. | 2000-02-10 | 86 | 0 |
| K993339 | ENDOPEARL WITH THREADER | Linvatec Corp. | 1999-12-10 | 66 | 0 |
| K991024 | BONE BULLET SUTURE ANCHOR | Linvatec Corp. | 1999-11-16 | 232 | 0 |
| K990194 | BIOBUTTON | Linvatec Corp. | 1999-09-17 | 239 | 0 |
| K991830 | CAPSULAR SHRINKAGE ELECTRODE | Linvatec Corp. | 1999-08-20 | 84 | 0 |
| K991715 | BIOSTINGER-V BIOABSORBABLE MENISCAL REPAIR DEVICE | Linvatec Corp. | 1999-08-06 | 78 | 0 |
| K990770 | BIORC ANCHOR | Linvatec Corp. | 1999-07-30 | 143 | 0 |
| K990524 | E9000 SYSTEM | Linvatec Corp. | 1999-07-15 | 146 | 0 |
| K984171 | ENDOPEARL | Linvatec Corp. | 1999-04-29 | 160 | 0 |
| K983652 | ABLATOR ELECTRODE | Linvatec Corp. | 1999-03-23 | 155 | 0 |
| K983186 | BIO-ANCHOR, PRE-LOADED BIOABSORBABLE SUTURE ANCHOR | Linvatec Corp. | 1998-10-21 | 40 | 0 |
| K981636 | INTEGRATED DRIVE/PUMP SYSTEM | Linvatec Corp. | 1998-08-20 | 104 | 1 |
| K981692 | MENISCAL REPAIR DEVICE | Linvatec Corp. | 1998-07-27 | 75 | 0 |
| K981637 | INTEGRATED DRIVE/PUMP SYSTEM FOR OTOLARYNGOLOGY | Linvatec Corp. | 1998-07-20 | 73 | 0 |
| K981269 | UNIVERSAL DRIVE SYSTEM | Linvatec Corp. | 1998-06-24 | 78 | 3 |
| K974538 | MENISCAL REPAIR DEVICE | Linvatec Corp. | 1998-03-03 | 90 | 0 |
| K973758 | BIOSCREW ABSORBABLE INTERFERENCE SREW | Linvatec Corp. | 1998-02-27 | 148 | 0 |
| K963932 | PRELOADED SOFT TISSUE ANCHOR | Linvatec Corp. | 1997-06-20 | 262 | 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