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 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 31, 2004 | Depuy Orthopaedics, Inc. Depuy brand ACE trochanteric nail; sterile, standard, 130 deg x 11 mm; Product 903211230. Terminated |
HSB | K010780 |
| Jan 31, 2004 | Depuy Orthopaedics, Inc. Depuy brand ACE trochanteric nail; sterile, standard, 125 deg x 11 mm; Product 903211225. Terminated |
HSB | K010780 |
| Jan 31, 2004 | Depuy Orthopaedics, Inc. Depuy brand ACE trochanteric nail; sterile, short, 180 x 11 x 135; Product 903211135. Terminated |
HSB | K010780 |
| Jan 31, 2004 | Depuy Orthopaedics, Inc. Depuy brand ACE trochanteric nail; sterile, short, 180 x 11 130; Product 903211130. Terminated |
HSB | K010780 |
| Jan 31, 2004 | Depuy Orthopaedics, Inc. Depuy brand ACE trochanteric nail; sterile, short, 180 x 11 x 125; Product 903211125. Terminated |
HSB | K010780 |
| Jan 31, 2004 | Depuy Orthopaedics, Inc. Depuy brand ACE trochanteric nail; sterile, short, 140 deg x 9 mm; Product 903209140. Terminated |
HSB | K010780 |
| Jan 31, 2004 | Depuy Orthopaedics, Inc. Depuy brand ACE trochanteric nail; sterile, short, 135 deg x 9 mm; Product 903209135. Terminated |
HSB | K010780 |
| Jan 31, 2004 | Depuy Orthopaedics, Inc. Depuy brand ACE trochanteric nail; sterile, short 130 deg x 9 mm; Product 903209130. Terminated |
HSB | K010780 |
| Jan 31, 2004 | Depuy Orthopaedics, Inc. Depuy brand ACE trochanteric nail; sterile, short 125 deg x 9 mm; Product 903209125. Terminated |
HSB | K010780 |
| Jan 31, 2004 | Depuy Orthopaedics, Inc. Depuy brand ACE trochanteric nail; sterile, long, right hip, 400 x 13 x 130; Product 926213400. Terminated |
HSB | K013563 |
| Jan 31, 2004 | Depuy Orthopaedics, Inc. Depuy brand ACE trochanteric nail; sterile, long, right hip, 380 x 13 x 130; Product 926213380. Terminated |
HSB | K013563 |
| Jan 31, 2004 | Depuy Orthopaedics, Inc. Depuy brand ACE trochanteric nail; sterile, long, right hip, 360 x 13 x 130; Product 926213360. Terminated |
HSB | K013563 |
| Jan 31, 2004 | Depuy Orthopaedics, Inc. Depuy brand ACE trochanteric nail; sterile, long, right hip, 340 x 13 x 130; Product 926213340. Terminated |
HSB | K013563 |
| Jan 31, 2004 | Depuy Orthopaedics, Inc. Depuy brand ACE trochanteric nail; sterile, long, right hip, 420 x 11 x 130; Product 926211420. Terminated |
HSB | K013563 |
| Jan 31, 2004 | Depuy Orthopaedics, Inc. Depuy brand ACE trochanteric nail; sterile, long, right hip, 400 x 11 x 130; Product 926211400. Terminated |
HSB | K013563 |
| Jan 31, 2004 | Depuy Orthopaedics, Inc. Depuy brand ACE trochanteric nail; sterile, long, right hip, 380 x 11 x 130; Product 926211380. Terminated |
HSB | K013563 |
| Jan 31, 2004 | Depuy Orthopaedics, Inc. Depuy brand ACE trochanteric nail; sterile, long, right hip, 360 x 11 x 130; Product 926211360. Terminated |
HSB | K013563 |
| Jan 31, 2004 | Depuy Orthopaedics, Inc. Depuy brand ACE trochanteric nail; sterile, long, right hip, 340 x 11 x 130; Product 926211340. Terminated |
HSB | K013563 |
| Jan 31, 2004 | Depuy Orthopaedics, Inc. Depuy brand ACE trochanteric nail; sterile, long, right hip, 320 x 11 x 130; Product 926211320. Terminated |
HSB | K013563 |
| Jan 31, 2004 | Depuy Orthopaedics, Inc. Depuy brand ACE trochanteric nail; sterile, long, right hip, 400 x 9 x 130; Product 926209400. Terminated |
HSB | K013563 |
| Jan 31, 2004 | Depuy Orthopaedics, Inc. Depuy brand ACE trochanteric nail; sterile, long, right hip, 380 x 9 x 130; Product 926209380. Terminated |
HSB | K013563 |
| Jan 31, 2004 | Depuy Orthopaedics, Inc. Depuy brand ACE trochanteric nail; sterile, long, right hip, 390 x 9 x 130; Product 926209360. Terminated |
HSB | K013563 |
| Jan 31, 2004 | Depuy Orthopaedics, Inc. Depuy brand ACE trochanteric nail; sterile, long, right hip, 340 x 9 x 130; Product 926209340. Terminated |
HSB | K013563 |
| Jan 31, 2004 | Depuy Orthopaedics, Inc. Depuy brand ACE trochanteric nail; sterile, long, right hip, 320 x 9 x 130; Product 926209320. Terminated |
HSB | K013563 |
| Jan 31, 2004 | Depuy Orthopaedics, Inc. Depuy brand ACE trochanteric nail; sterile, long, left hip, 420 x 13 x 130; Product 925213420. Terminated |
HSB | K013563 |
| Jan 31, 2004 | Depuy Orthopaedics, Inc. Depuy brand ACE trochanteric nail; sterile, long, left hip, 400 x 13 x 130; Product 925213400. Terminated |
HSB | K013563 |
| Jan 31, 2004 | Depuy Orthopaedics, Inc. Depuy brand ACE trochanteric nail; sterile, long, left hip, 380 x 13 x 130; Product 925213380. Terminated |
HSB | K013563 |
| Jan 31, 2004 | Depuy Orthopaedics, Inc. Depuy brand ACE trochanteric nail; sterile, long, left hip, 360 x 13 x 130; Product 925213360. Terminated |
HSB | K013563 |
| Jan 31, 2004 | Depuy Orthopaedics, Inc. Depuy brand ACE trochanteric nail; sterile, long, left hip, 340 x 13 x 130; Product 925213340. Terminated |
HSB | K013563 |
| Jan 31, 2004 | Depuy Orthopaedics, Inc. Depuy brand ACE trochanteric nail; sterile, long, left hip, 420 x 11 x 130; Product 925211420. Terminated |
HSB | K013563 |
| Jan 31, 2004 | Depuy Orthopaedics, Inc. Depuy brand ACE trochanteric nail; sterile, long, left hip, 400 x 11 x 130; Product 925211400. Terminated |
HSB | K013563 |
| Jan 31, 2004 | Depuy Orthopaedics, Inc. Depuy brand ACE trochanteric nail; sterile, long, left hip, 380 x 11 x 130; Product 925211380. Terminated |
HSB | K013563 |
| Jan 31, 2004 | Depuy Orthopaedics, Inc. Depuy brand ACE trochanteric nail; sterile, long, left hip, 360 x 11 x 130; Product 925211360. Terminated |
HSB | K013563 |
| Jan 31, 2004 | Depuy Orthopaedics, Inc. Depuy brand ACE trochanteric nail; sterile, long, left hip, 340 x 11 x 130; Product 925211340. Terminated |
HSB | K013563 |
| Jan 31, 2004 | Depuy Orthopaedics, Inc. Depuy brand ACE trochanteric nail; sterile, long, left hip, 400 x 9 x 130; Product 925209400. Terminated |
HSB | K013563 |
| Jan 31, 2004 | Depuy Orthopaedics, Inc. Depuy brand ACE trochanteric nail; sterile, long, left hip, 380 x 9 x 130; Product 925209380. Terminated |
HSB | K013563 |
| Jan 31, 2004 | Depuy Orthopaedics, Inc. Depuy brand ACE trochanteric nail; sterile, long, left hip, 360 x 9 x 130; Product 925209360. Terminated |
HSB | K013563 |
| Jan 31, 2004 | Depuy Orthopaedics, Inc. Depuy brand ACE trochanteric nail; sterile, long, left hip, 340 x 9 x 130; Product 925209340. Terminated |
HSB | K013563 |
| Jan 31, 2004 | Depuy Orthopaedics, Inc. Depuy brand ACE trochanteric nail; sterile, long, left hip, 320 x 11 x 130; Product 925200320. Terminated |
HSB | K013563 |
| Oct 15, 2003 | Stryker Howmedica Osteonics T2 Tibia Nail, Standard 9 x 300 mm, T2 Tibia System, Catalog No. 1822-0930S. Terminated |
HSB | K003018 |
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