Company ยท US
Acu Med, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1990 to 2002. Name variants (Inc, Corp, punctuation) are merged.
48510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| HSB | Rod, Fixation, Intramedullary And Accessories | 9 |
| HWC | Screw, Fixation, Bone | 9 |
| HRS | Plate, Fixation, Bone | 4 |
| HTN | Washer, Bolt Nut | 4 |
| JDQ | Cerclage, Fixation | 3 |
| JEC | Component, Traction, Invasive | 3 |
| HRX | Arthroscope | 2 |
| HTY | Pin, Fixation, Smooth | 2 |
| LZJ | Prosthesis, Toe (Metatarsophalangeal), Joint, Metal/Polymer, Semi-Constrained | 2 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | 2 |
| EZX | Mesh, Surgical, Metal | 1 |
| HSD | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | 1 |
| JDR | Staple, Fixation, Bone | 1 |
| JDS | Nail, Fixation, Bone | 1 |
| KIJ | Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment | 1 |
| KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | 1 |
| LRN | Wire, Surgical | 1 |
| MQX | Needle, Acupuncture, Single Use | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 17, 2002 | K021321 | WRIST FUSION PLATE Acu Med, Inc. | HRS |
| Dec 19, 2001 | K013616 | POLARUS CAP SCREW Acu Med, Inc. | HSB |
| Nov 7, 2001 | K012655 | CONGRUENT BONE PLATE SYSTEM Acu Med, Inc. | HRS |
| Feb 4, 2000 | K992525 | ACUMED MODULAR SHOULDER SYSTEM Acu Med, Inc. | HSD |
| Jan 13, 2000 | K993657 | ACUMED SUTURE ANCHOR Acu Med, Inc. | MBI |
| Mar 16, 1998 | K980103 | ACUMED SUTURE ANCHOR Acu Med, Inc. | MBI |
| Mar 17, 1997 | K965028 | ACUMED SUTURE WASHER Acu Med, Inc. | HTN |
| Feb 19, 1997 | K965029 | STABLELOC II EXTERNAL FIXATOR Acu Med, Inc. | JEC |
| Dec 9, 1996 | K964500 | ACUMED TENSION BAND PIN Acu Med, Inc. | HTY |
| Oct 28, 1996 | K963026 | TBD Acu Med, Inc. | HSB |
| Oct 10, 1996 | K963118 | EXTREMITY BONE SCREW Acu Med, Inc. | HWC |
| Oct 1, 1996 | K963077 | TBD Acu Med, Inc. | HSB |
| Jul 24, 1996 | K962091 | POLARUS AF ROD Acu Med, Inc. | HSB |
| Jul 10, 1996 | K960769 | ACUPUNCTURE NEEDLE PACK Acu-Med, Inc. | MQX |
| May 7, 1996 | K960711 | ACUMED BONE GRAFT SYSTEM Acu Med, Inc. | KIJ |
| May 3, 1996 | K960651 | CERCLAGE WIRE CRIMP BLOCK Acu-Med, Inc. | JDQ |
| Jan 17, 1996 | K954148 | SUTURE WASHER Acu Med, Inc. | HTN |
| Oct 5, 1995 | K952330 | EXTERNAL FIXATOR Acu Med, Inc. | JEC |
| Aug 11, 1995 | K951740 | INTRAMEDULARY FIXATION ROD Acu Med, Inc. | HSB |
| Jul 31, 1995 | K950864 | GTS GREAT TOE SYSTEM - (METATARSAL COMPONENT WITH POROUS COATING) Acu Med, Inc. | LZJ |
| Jul 13, 1995 | K952534 | TENTATIVELY POLARUS EX ROD Acu-Med, Inc. | HSB |
| Jul 12, 1995 | K943855 | BONE FIXATION NAIL Acu Med, Inc. | JDS |
| Jul 6, 1995 | K951673 | ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Acu Med, Inc. | HSB |
| Jul 6, 1995 | K943856 | FIXATION PINS/WIRES Acu Med, Inc. | HTY |
| May 5, 1995 | K944330 | ACUTRAK PLUS FIXATION SYSTEM Acu Med, Inc. | HWC |
| Apr 13, 1995 | K942359 | BONE PLATE SYSTEM Acu Med, Inc. | HRS |
| Feb 1, 1995 | K945027 | TROCHANTER MESH Acu Med, Inc. | EZX |
| Jan 27, 1995 | K943857 | EXTERNAL FIXATOR Acu Med, Inc. | JEC |
| Dec 20, 1994 | K943782 | BONE SCREW WASHER Acu Med, Inc. | HTN |
| Dec 15, 1994 | K942787 | BONE ANCHOR Acu Med, Inc. | JDR |
| Dec 5, 1994 | K942341 | CANNULATED CANCELLOUS BONE SCREW Acu Med, Inc. | HWC |
| Dec 5, 1994 | K942340 | CORTICAL BONE SCREW Acu Med, Inc. | HWC |
| Nov 9, 1994 | K942603 | ORTHOPAEDIC WIRES Acu Med, Inc. | LRN |
| Jun 28, 1994 | K932099 | ACUMED FLEXIBLE CANNULA Acu Med, Inc. | HRX |
| Mar 24, 1994 | K933638 | ACUMED CARPAL TUNNEL RELEASE KIT Acu Med, Inc. | HRX |
| Feb 23, 1994 | K932027 | OREGON FIXATION SYSTEM INTERFERENCE SCREW Acu Med, Inc. | HWC |
| Feb 22, 1994 | K933361 | ACUMED RADIUS ROD Acu Med, Inc. | HSB |
| Feb 22, 1994 | K931246 | CERCLAGE WIRE CRIMP SLEEVE Acu Med, Inc. | JDQ |
| Feb 15, 1994 | K931244 | BONE PLATE Acu Med, Inc. | HRS |
| Jul 26, 1993 | K930834 | ACUTRACT Acu Med, Inc. | HWC |
| Aug 5, 1992 | K920666 | INTRAMEDULARY FIXATION ROD Acu Med, Inc. | HSB |
| Jun 26, 1992 | K921480 | OSTEO-CLAGE(TM) CERCIAGE CABLE SYSTEM Acu-Med, Inc. | JDQ |
| Jun 19, 1992 | K920667 | GREAT TOE IMPLANT Acu Med, Inc. | LZJ |
| Feb 13, 1992 | K915613 | BONE SCREW 3.5 MM Acu Med, Inc. | HWC |
| Jan 13, 1992 | K910976 | OREGON FIXATION SCREW Acu Med, Inc. | HWC |
| Aug 23, 1991 | K910193 | HUENE FIXATION SCREW Acu-Med, Inc. | HWC |
| Jul 25, 1991 | K910186 | WYMAN SUTURE WASHER Acu Med, Inc. | HTN |
| Dec 20, 1990 | K904383 | ACUFIT TOTAL HIP Acu Med, Inc. | KWY |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||