Product code HSZ
- Device name
- Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment
- Medical specialty
- General, Plastic Surgery
- Device class
- 1
- Regulation number
- 878.4820
- Review panel
- OR
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K991588 | EMS SWISS ORTHOCLAST | (Ems Sa) Electro Medical Systems | 1999-07-21 |
| K972860 | CURVTEK TSR SYSTEM | Biolectron, Inc. | 1997-10-31 |
| K970345 | ALIGNMENT INSTRUMENT | Richard Wolf Medical Instruments Corp. | 1997-04-29 |
| K955084 | ASPACH 65,000 (MODIFICATION) | The Anspach Effort, Inc. | 1996-01-17 |
| K954080 | SODEM HIGH SPEED SYSTEM | Sodem Diffusion SA | 1995-10-16 |
| K944590 | ETHICON DRILL BIT AND DRILL GUIDE | ETHICON, Inc. | 1995-05-11 |
| K934336 | SPINALPLANE | Synvasive Technology, Inc. | 1995-03-10 |
| K940276 | FILTER, DIFFUSER | Anspach Mfg., Inc. | 1994-11-16 |
| K942760 | PNEUMATIC WIRE TENSIONER | Smith & Nephew Richards, Inc. | 1994-09-06 |
| K941681 | ARTHREX CIRCULAR HARVESTING SAW | Arthrex, Inc. | 1994-08-25 |
| K935367 | TAVA WIRE-DRIVER | Tava Surgical Instruments | 1994-04-21 |
| K934431 | PNEUMATIC WIRE TENSIONER | Smith & Nephew Richards, Inc. | 1994-01-27 |
| K930784 | THE DE SOUTTER M193 REAMER | De Soutter Medical, Ltd. | 1993-10-27 |
| K930785 | THE DE SOUTTER M182 DRILL | De Soutter Medical, Ltd. | 1993-10-27 |
| K926547 | MEDNEXT 1000 BONE DISSECTING SYSTEM | Mednext, Inc. | 1993-07-22 |
| K922661 | HHI PNEUMATIC ROTARY DRILL | H&H Instruments | 1992-09-18 |
| K915139 | MODEL 2250-000 ZIMMER STYLE SAGITTAL SAW MODULE | Micro Surgical Instruments Corp. | 1992-02-05 |
| K914845 | M170 PNEUMATICALLY OPERATED OSCILLATING SAW | Desutter Medical , Ltd. | 1992-01-13 |
| K913629 | JOHNSON AND JOHNSON POWER SYSTEM | Johnson & Johnson Orthopaedics, Inc. | 1991-11-13 |
| K913559 | OSTEO COMPLETE PNEUMATIC DRILL-OSCILAIR | Osteo AG | 1991-11-07 |
| K905027 | CUP OUT | Anspach Mfg., Inc. | 1991-02-05 |
| K905277 | MICRO-AIRE 4220-000 OSCILLATING SAW | Micro Surgical Instruments Corp. | 1991-01-08 |
| K905187 | BONE RASPS | Micro Surgical Instruments Corp. | 1990-12-19 |
| K904949 | A.O. SYNTHES,TAP(REPLACEMENT)VARIOUS MODEL NUMBERS | Micro-Aire Surgical Instruments, Inc. | 1990-11-26 |
| K903713 | OSTEOTOME MODEL NUMBERS 2500-228 & 2500-229 | Micro-Aire Surgical Instruments, Inc. | 1990-09-14 |
| K901455 | THE KIRSCHNER UNIVERSAL POWER TOOL SYSTEM | Kirschner Medical Corp. | 1990-05-14 |
| K900210 | BONE HARVESTER SYSTEM & OSTEOTOME SYSTEM 2500 | Micro-Aire Surgical Instruments, Inc. | 1990-02-02 |
| K885229 | MODIFIED GLENOID ARCUATE DRILL & DISP. FLEXI-BITS | Romano Surgical Instrumentation, Inc. | 1989-09-29 |
| K895121 | INTERMEDICS POWER BROACH IMPACTOR | Intermedics Orthopedics | 1989-09-11 |
| K885273 | MICRO SURGICAL INSTRUMENT SYSTEM | Tava Surgical Instruments | 1989-01-30 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10845854028636 | POWERPRO | Conmed Corporation | 2023-09-01 |
| 10845854036198 | POWERPRO | Conmed Corporation | 2023-09-01 |
| 10845854036204 | POWERPRO | Conmed Corporation | 2023-09-01 |
| 10845854028384 | POWERPRO | Conmed Corporation | 2021-04-19 |
| 10886982186041 | NA | Synthes GmbH | 2019-12-27 |
| 10886982186126 | NA | Synthes GmbH | 2019-12-27 |
| 10886982185914 | NA | Synthes GmbH | 2019-12-26 |
| 10886982185976 | NA | Synthes GmbH | 2019-12-26 |
| 10886982186119 | NA | Synthes GmbH | 2019-12-26 |
| 10886982186034 | NA | Synthes GmbH | 2019-12-26 |
| 10886982186164 | NA | Synthes GmbH | 2018-09-21 |
| 10886982186157 | NA | Synthes GmbH | 2018-09-21 |
| 10886982186140 | NA | Synthes GmbH | 2018-09-21 |
| 10886982186133 | NA | Synthes GmbH | 2018-09-21 |
| 10886982186188 | NA | Synthes GmbH | 2018-09-21 |
| 10886982186102 | NA | Synthes GmbH | 2018-09-21 |
| 10886982186072 | NA | Synthes GmbH | 2018-09-21 |
| 10886982186058 | NA | Synthes GmbH | 2018-09-21 |
| 10886982186195 | NA | Synthes GmbH | 2018-09-21 |
| 10886982186027 | NA | Synthes GmbH | 2018-09-21 |
| 10886982186010 | NA | Synthes GmbH | 2018-09-21 |
| 10886982186003 | NA | Synthes GmbH | 2018-09-21 |
| 10886982185990 | NA | Synthes GmbH | 2018-09-21 |
| 10886982185983 | NA | Synthes GmbH | 2018-09-21 |
| 10886982185969 | NA | Synthes GmbH | 2018-09-21 |
| 10886982185945 | NA | Synthes GmbH | 2018-09-21 |
| 10886982185938 | NA | Synthes GmbH | 2018-09-21 |
| 10886982185921 | NA | Synthes GmbH | 2018-09-21 |
| 10886982185907 | NA | Synthes GmbH | 2018-09-21 |
| 10886982185877 | NA | Synthes GmbH | 2018-09-21 |