Company ยท US
Acromed Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1984 to 1998. Name variants (Inc, Corp, punctuation) are merged.
41510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 21, 1998 | K980485 | ISOLA SPINAL SYSTEM Acromed Corp. | MNI |
| Jun 30, 1998 | K981714 | TIMX LOW BACK SYSTEM TITANIUM MX ROD BASED LOW BACK SYSTEM Acromed Corp. | MNH |
| May 29, 1998 | K981113 | PEDIATRIC PRC Acromed Corp. | MNH |
| Apr 29, 1998 | K981274 | ACROMED TIMX PLATE BASED LOW BACK SYSTEM Acromed Corp. | MNH |
| Apr 14, 1998 | K980228 | UNIVERSITY PLATE ANTERIOR SYSTEM Acromed Corp. | KWQ |
| Mar 5, 1998 | K974757 | KANEDA ANTERIOR SCOLIOSIS SYSTEM KASS Acromed Corp. | KWQ |
| Oct 1, 1997 | K972718 | M-2 ANTERIOR PLATE SYSTEM Acromed Corp. | KWQ |
| Jun 11, 1997 | K971248 | KANEDA SR ANTERIOR SPINAL SYSTEM Acromed Corp. | KWQ |
| Jun 11, 1997 | K970955 | ACROMED ANTERIOR CERVICAL STABILIZATION SYSTEM Acromed Corp. | KWQ |
| Jun 3, 1997 | K970950 | EASY ROD Acromed Corp. | MNH |
| May 8, 1997 | K965102 | ACROMED PEDICLE SCREW Acromed Corp. | MNH |
| Apr 3, 1997 | K970462 | ACROMED ANTERIOR CERVICAL STABILIZATION SYSTEM Acromed Corp. | KWQ |
| Mar 14, 1997 | K965046 | ISOLA TWISTER CONNECTOR Acromed Corp. | MNH |
| Feb 19, 1997 | K953978 | ANTERIOR DYNAMIZED SYSTEM Acromed Corp. | KWQ |
| Dec 16, 1996 | K964007 | ACROMED CABLE/WIRE PEDICLE SCREW Acromed Corp. | MNH |
| Nov 27, 1996 | K962984 | ISOLA PEDIATRIC COMPONENTS Acromed Corp. | KWP |
| Nov 14, 1996 | K963639 | ACROMED PEDICLE SCREW Acromed Corp. | KWP |
| Oct 22, 1996 | K962645 | ISOLA TWISTER CONNECTOR Acromed Corp. | MNH |
| Jan 22, 1996 | K952236 | ISOLA SYSTEM Acromed Corp. | MNH |
| Aug 21, 1995 | K951657 | VSP (VARIABLE SCREW PLACEMENT) SPINAL FIXATION SYSTEM, PEDICLE SCREW(S), SPINE PLATE(S), WASHER(S) & NUT(S) Acromed Corp. | MNH |
| Aug 11, 1995 | K951116 | ACROMED PEDICLE SCREW Acromed Corp. | MNH |
| Jun 22, 1995 | K944737 | ISOLA SPINE SYSTEM Acromed Corp. | MNH |
| May 30, 1995 | K944756 | ISOLA OPEN AND CLOSED SCREWS Acromed Corp. | MNH |
| May 5, 1995 | K944736 | VSP (VARIABLE SCREW PLACEMENT) Acromed Corp. | MNH |
| Feb 9, 1995 | K943819 | ISOLA ANTERIOR SYSTEM Acromed Corp. | KWQ |
| May 20, 1993 | K923703 | KANEDA ANTERIOR SPINAL MULTISEGMENTAL FIXATION DEV Acromed Corp. | KWQ |
| May 18, 1993 | K922504 | ISOLA(R) TANDEM CONNECTOR Acromed Corp. | KWP |
| Dec 31, 1992 | K921090 | ISOLA(R) TRANSVERSE ROD DUAL CONNECTOR Acromed Corp. | KWP |
| Dec 31, 1992 | K920392 | ISOLA SPINE SYSTEM: PLATE-ROD COMBINATION Acromed Corp. | KWP |
| Sep 5, 1991 | K904446 | CASF (TM) (CONTOURED ANTERIOR SPINAL FIXATON SYS.) Acromed Corp. | KWQ |
| Jun 28, 1991 | K911528 | ISOLA(TM) SPINE SYSTEM - ILIAC SCREW Acromed Corp. | KWP |
| Jun 21, 1991 | K911394 | ISOLA(TM) SPINE SYSTEM--EYE ROD Acromed Corp. | KWP |
| Mar 21, 1991 | K905826 | ISOLA SLOTTED CONNECT/ANGLED SLOTTED CONNECTOR Acromed Corp. | KWP |
| Feb 15, 1991 | K905184 | ISOLA(TM) SPINE SYSTEM TOP ENTRY HOOK Acromed Corp. | KWP |
| Dec 27, 1990 | K903376 | ACROMED SACRAL SCREW Acromed Corp. | KWP |
| Nov 22, 1989 | K895441 | ACROMED BUTTON SPINAL WIRE Acromed Corp. | KWP |
| Nov 22, 1989 | K895439 | ACROMED BEADED SUBLAMINAR WIRE Acromed Corp. | KWP |
| Nov 22, 1989 | K895413 | ACROMED DOUBLE SUBLAMINAR WIRE Acromed Corp. | KWP |
| Nov 30, 1988 | K873826 | ACROMED/KANEDA ANTERIOR SPINAL INSTRUMENTATION Acromed Corp. | KWQ |
| Feb 18, 1988 | K874882 | ACROMED CROSS ROD CONNECTOR Acromed Corp. | KWP |
| Oct 25, 1984 | K842845 | BONE MILL BONE GRINDER Acromed Corp. |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||