Panels › Orthopedic › Product code HSB · Class 2
Rod, Fixation, Intramedullary And Accessories
Regulation 888.3020
20510(k)s in 12 months (532 all time)
19recalls in 12 months (690 all time)
680recalls that name a 510(k)
Top companies in HSB
| Company | 510(k)s | Recalls |
|---|---|---|
| Zimmer Biomet, Inc. | 0 | 295 |
| DePuy Orthopaedics, Inc. | 9 | 116 |
| Zimmer GmbH | 23 | 50 |
| Stryker | 12 | 37 |
| Howmedica Osteonics | 39 | 0 |
| OrthoPediatrics Corp. | 7 | 31 |
| Ebi, L.P. | 1 | 31 |
| Advanced Orthopaedic Solutions, Inc. | 15 | 12 |
| NuVasive Specialized Orthopedics | 18 | 9 |
| Synthes (Usa) | 23 | 4 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 24, 1996 | K962091 | POLARUS AF ROD Acu Med, Inc. | HSB |
| May 8, 1996 | K961027 | ORTHOFIX TIBIAL NAILING SYSTEM Orthofix, Inc. | HSB |
| Mar 22, 1996 | K960524 | ALTA CFX IM ROD SYSTEM Howmedica Corp. | HSB |
| Mar 13, 1996 | K955761 | TIBIA ORTHONAIL Orthologic Corp. | HSB |
| Mar 8, 1996 | K932330 | TI-6AL-7NB URTN Synthes (Usa) | HSB |
| Jan 25, 1996 | K954756 | FIXANO I.F.O (INTERLOCKING FLEXIBLE OSTEOSYNTHESIS) SYSTEM Ferguson Medical | HSB |
| Dec 13, 1995 | K954554 | ALTA TIBIAL/HUMERAL ROD Howmedica Corp. | HSB |
| Oct 31, 1995 | K953334 | SYNTHES FLEXNAIL Synthes (Usa) | HSB |
| Sep 29, 1995 | K952923 | INTRAMEDULLARY COMPRESSION ARTHRODESIS (ICA) NAIL Howmedica Corp. | HSB |
| Sep 15, 1995 | K952739 | ORTHONAIL Orthologic Corp. | HSB |
| Aug 11, 1995 | K951740 | INTRAMEDULARY FIXATION ROD Acu Med, Inc. | HSB |
| Jul 13, 1995 | K952534 | TENTATIVELY POLARUS EX ROD Acu-Med, Inc. | HSB |
| Jul 6, 1995 | K951673 | ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Acu Med, Inc. | HSB |
| May 19, 1995 | K950394 | TIBIA-TALUS-CALCANEUS NAIL Smith & Nephew Richards, Inc. | HSB |
| Mar 21, 1995 | K935383 | FEMROD AND FEMROD RECON INSERT Applied Osteo Systems, Inc. | HSB |
| Jan 27, 1995 | K933995 | TRUE/FLEXTM FEMUR RODS, CAPS, SCREWS AND INSTRUMENTATION Applied Osteo Systems, Inc. | HSB |
| Nov 28, 1994 | K944501 | TRUE/FLEX INTRAMEDULLARY ROD END-CAP Applied Osteo Systems, Inc. | HSB |
| Oct 11, 1994 | K935295 | ALTA FEMORAL INTRAMEDULLARY RODS/CFX RODS MODIFICATION Howmedica Corp. | HSB |
| Jun 30, 1994 | K933340 | OSTEO INTERLOCKING-COMPRESSION NAIL Osteo AG | HSB |
| Mar 29, 1994 | K930972 | INTRAMEDULLARY SYSTEMS Baumer Ortopedia , Ltd., BR | HSB |
| Mar 22, 1994 | K934962 | AIM SUPRACONDYLAR NAIL Ace Orthopedic Manufacturing Co. | HSB |
| Mar 22, 1994 | K934643 | ACE HUMERAL NAIL Ace Orthopedic Manufacturing Co. | HSB |
| Mar 14, 1994 | K933518 | SYNTHES UNREAMED HUMERAL NAIL (URHN) Synthes (Usa) | HSB |
| Mar 10, 1994 | K932593 | ACCESS TO SYNTHES TI-6A1-7NB UNREAMED FEMORAL NAIL Synthes (Usa) | HSB |
| Feb 22, 1994 | K934148 | TRUE/FLEX CLAVICLE RODS Applied Osteo Systems, Inc. | HSB |
| Feb 22, 1994 | K933361 | ACUMED RADIUS ROD Acu Med, Inc. | HSB |
| Feb 22, 1994 | K933027 | THE MODULAR NAIL Smith & Nephew Richards, Inc. | HSB |
| Jul 2, 1993 | K931256 | SEIDEL HUMERAL LOCKING NAIL Howmedica Corp. | HSB |
| Jun 17, 1993 | K926232 | ALTA CFX ROD SYSTEM Howmedica Corp. | HSB |
| Jun 17, 1993 | K926213 | MODIFIED ZICKEL INTRAMEDULLARY ROD SYSTEM Osteo Technology, Inc. | HSB |
| Mar 4, 1993 | K925544 | SEIDEL HUMERAL LOCKING NAIL & ADDITIONAL LENGTHS Howmedica Corp. | HSB |
| Jan 21, 1993 | K923597 | SYNTHES TITANIUM UNREAMED FEMORAL NAIL Synthes (Usa) | HSB |
| Jan 21, 1993 | K923580 | SYNTHES TI-6AI-7NB UNREAMED FEMORAL NAIL Synthes (Usa) | HSB |
| Nov 24, 1992 | K924656 | TRUE/ FLEX FIBULA RODS Applied Osteo Systems, Inc. | HSB |
| Sep 21, 1992 | K922266 | ALTA FEMORAL INTRAMEDULLARY ROD SYSTEM, ADD SIZES Howmedica Corp. | HSB |
| Aug 5, 1992 | K920666 | INTRAMEDULARY FIXATION ROD Acu Med, Inc. | HSB |
| Jul 23, 1992 | K922196 | OSTEO TIBIA NAIL Osteo AG | HSB |
| Jul 23, 1992 | K922195 | OSTEO FEMORAL NAIL Osteo AG | HSB |
| Apr 28, 1992 | K920598 | TRUE/FLEX HUMERUS CAP Applied Osteo Systems, Inc. | HSB |
| Mar 2, 1992 | K915435 | INTERLOCKING TIBIAL NAILING SYSTEM Stryker Corp. | HSB |
| Jan 17, 1992 | K913949 | TRUE/FLEX HUMERUS, ULNA & RADIUS INTRAMED RODS SYS Applied Osteo Systems, Inc. | HSB |
| Jan 13, 1992 | K912930 | INTERLOCKING FEMORAL NAILING SYSTEM Stryker Corp. | HSB |
| Oct 15, 1991 | K912710 | TRUE/FLEX TIBIAL RODS WITH CAP Applied Osteo Systems, Inc. | HSB |
| Sep 23, 1991 | K912420 | ORTHOFIX UNREAMED TIBIAL NAIL SYSTEM Scientific Research | HSB |
| Jul 8, 1991 | K911554 | AIM TIBIAL NAIL Ace Medical Co. | HSB |
| Mar 5, 1991 | K903526 | ALTA(R) PFX IM ROD Howmedica Corp. | HSB |
| Jul 30, 1990 | K903256 | HANSEN-STREET TYPE INTRAMEDULLARY NAIL Onyx Medical Corp. | HSB |
| Jul 12, 1990 | K902264 | TRUE/FLEX HUMERUS, ULNA AND RADIUS INTRAMEDULLARY Applied Osteo Systems, Inc. | HSB |
| Nov 16, 1989 | K893377 | RUSSELL-TAYLOR INTRAMEDULLARY KNEE FUSION NAILS Richards Medical Co., Inc. | HSB |
| Jun 5, 1989 | K890936 | ALTA HOLLOW TIBIAL RODS Howmedica Corp. | HSB |
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