FDA Product Code
FDA Product Code HSZ — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.4820
510(k) Clearances — 56 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K991588 | EMS SWISS ORTHOCLAST | (Ems Sa) Electro Medical Systems | 1999-07-21 | Traditional | PDF ↗ |
| K972860 | CURVTEK TSR SYSTEM | Biolectron, Inc. | 1997-10-31 | Traditional | PDF ↗ |
| K970345 | ALIGNMENT INSTRUMENT | Richard Wolf Medical Instruments Corp. | 1997-04-29 | Traditional | PDF ↗ |
| K955084 | ASPACH 65,000 (MODIFICATION) | The Anspach Effort, Inc. | 1996-01-17 | Traditional | PDF ↗ |
| K954080 | SODEM HIGH SPEED SYSTEM | Sodem Diffusion SA | 1995-10-16 | Traditional | PDF ↗ |
| K944590 | ETHICON DRILL BIT AND DRILL GUIDE | ETHICON, Inc. | 1995-05-11 | Traditional | PDF ↗ |
| K934336 | SPINALPLANE | Synvasive Technology, Inc. | 1995-03-10 | Traditional | PDF ↗ |
| K940276 | FILTER, DIFFUSER | Anspach Mfg., Inc. | 1994-11-16 | Traditional | PDF ↗ |
| K942760 | PNEUMATIC WIRE TENSIONER | Smith & Nephew Richards, Inc. | 1994-09-06 | Traditional | PDF ↗ |
| K941681 | ARTHREX CIRCULAR HARVESTING SAW | Arthrex, Inc. | 1994-08-25 | Traditional | PDF ↗ |
| K935367 | TAVA WIRE-DRIVER | Tava Surgical Instruments | 1994-04-21 | Traditional | PDF ↗ |
| K934431 | PNEUMATIC WIRE TENSIONER | Smith & Nephew Richards, Inc. | 1994-01-27 | Traditional | PDF ↗ |
| K930784 | THE DE SOUTTER M193 REAMER | De Soutter Medical, Ltd. | 1993-10-27 | Traditional | PDF ↗ |
| K930785 | THE DE SOUTTER M182 DRILL | De Soutter Medical, Ltd. | 1993-10-27 | Traditional | PDF ↗ |
| K926547 | MEDNEXT 1000 BONE DISSECTING SYSTEM | Mednext, Inc. | 1993-07-22 | Traditional | PDF ↗ |
| K922661 | HHI PNEUMATIC ROTARY DRILL | H&H Instruments | 1992-09-18 | Traditional | PDF ↗ |
| K915139 | MODEL 2250-000 ZIMMER STYLE SAGITTAL SAW MODULE | Micro Surgical Instruments Corp. | 1992-02-05 | Traditional | PDF ↗ |
| K914845 | M170 PNEUMATICALLY OPERATED OSCILLATING SAW | Desutter Medical , Ltd. | 1992-01-13 | Traditional | PDF ↗ |
| K913629 | JOHNSON AND JOHNSON POWER SYSTEM | Johnson & Johnson Orthopaedics, Inc. | 1991-11-13 | Traditional | PDF ↗ |
| K913559 | OSTEO COMPLETE PNEUMATIC DRILL-OSCILAIR | Osteo AG | 1991-11-07 | Traditional | PDF ↗ |
| K905027 | CUP OUT | Anspach Mfg., Inc. | 1991-02-05 | Traditional | PDF ↗ |
| K905277 | MICRO-AIRE 4220-000 OSCILLATING SAW | Micro Surgical Instruments Corp. | 1991-01-08 | Traditional | PDF ↗ |
| K905187 | BONE RASPS | Micro Surgical Instruments Corp. | 1990-12-19 | Traditional | PDF ↗ |
| K904949 | A.O. SYNTHES,TAP(REPLACEMENT)VARIOUS MODEL NUMBERS | Micro-Aire Surgical Instruments, Inc. | 1990-11-26 | Traditional | PDF ↗ |
| K903713 | OSTEOTOME MODEL NUMBERS 2500-228 & 2500-229 | Micro-Aire Surgical Instruments, Inc. | 1990-09-14 | Traditional | PDF ↗ |
| K901455 | THE KIRSCHNER UNIVERSAL POWER TOOL SYSTEM | Kirschner Medical Corp. | 1990-05-14 | Traditional | PDF ↗ |
| K900210 | BONE HARVESTER SYSTEM & OSTEOTOME SYSTEM 2500 | Micro-Aire Surgical Instruments, Inc. | 1990-02-02 | Traditional | PDF ↗ |
| K885229 | MODIFIED GLENOID ARCUATE DRILL & DISP. FLEXI-BITS | Romano Surgical Instrumentation, Inc. | 1989-09-29 | Traditional | PDF ↗ |
| K895121 | INTERMEDICS POWER BROACH IMPACTOR | Intermedics Orthopedics | 1989-09-11 | Traditional | PDF ↗ |
| K885273 | MICRO SURGICAL INSTRUMENT SYSTEM | Tava Surgical Instruments | 1989-01-30 | Traditional | PDF ↗ |
| K884492 | MICRO SURGICAL INSTRUMENT SYSTEM | Tava Surgical Instruments | 1988-11-16 | Traditional | PDF ↗ |
| K881954 | CONCEPT POWER SYSTEM | Concept, Inc. | 1988-11-09 | Traditional | PDF ↗ |
| K880881 | ARTUS DISPOSABLE SHEATHS/CUTTERS | Acufex Microsurgical, Inc. | 1988-05-04 | Traditional | PDF ↗ |
| K881250 | ACE PNEUMATIC OSCILLATING SAW | Buckman Co., Inc. | 1988-04-15 | Traditional | PDF ↗ |
| K880074 | RSI GLENOID ARCUATE BONE DRILL W/DISP. FLEXI-BITS | Romano Surgical Instrumentation, Inc. | 1988-03-25 | Traditional | PDF ↗ |
| K880324 | MICRO-AIRE CEMENT REMOVAL TOOLS | Micro-Aire Surgical Instruments, Inc. | 1988-02-17 | Traditional | PDF ↗ |
| K872550 | 1.1 COUPLERS AND 1.2 ADAPTERS | Micro-Aire Surgical Instruments, Inc. | 1987-07-21 | Traditional | PDF ↗ |
| K871891 | KARL STORZ MODEL 28184 PNEUMATIC SHUTTLE SHAVER | KARL STORZ Endoscopy-America, Inc. | 1987-06-05 | Traditional | PDF ↗ |
| K871287 | ORTHOPEDIC DRILL GUIDE | Orthopedic Systems, Inc. | 1987-04-15 | Traditional | PDF ↗ |
| K864314 | EFTEKHAR RECHANNELIZATION DRILL GUIDE | The Anspach Effort, Inc. | 1986-11-19 | Traditional | PDF ↗ |
| K861405 | REPLACEMENT HOSES | Micro-Aire Surgical Instruments, Inc. | 1986-04-25 | Traditional | PDF ↗ |
| K851443 | MICRO-AIRE OSCILLATING SAW, 1740-000 & WIRE DRIVER | Micro-Aire Surgical Instruments, Inc. | 1985-05-03 | Traditional | PDF ↗ |
| K844130 | ACUFEX ARTHROSCOPIC SHAVER | Acufex Microsurgical, Inc. | 1985-03-21 | Traditional | PDF ↗ |
| K844131 | NUCLEOTOME | Medical Instrument Development Laboratories, Inc. | 1984-11-29 | Traditional | PDF ↗ |
| K840831 | ENDOTOME PNEUMATIC ORTHOPAEDIC CUT | Cabot Medical Corp. | 1984-04-04 | Traditional | PDF ↗ |
| K831756 | ANSPACH 65,000 | The Anspach Effort, Inc. | 1983-09-29 | Traditional | PDF ↗ |
| K811834 | MICRO OSCILLATING SAW | Micro-Aire Surgical Instruments, Inc. | 1981-07-20 | Traditional | PDF ↗ |
| K811005 | CORB TM COUNTERROTATING BIOPSY NEEDLE | Zimmer, Inc. | 1981-06-15 | Traditional | PDF ↗ |
| K803284 | OSTEO OSCILAIR | Richard'S Medical Equip., Inc. | 1981-01-09 | Traditional | PDF ↗ |
| K801329 | ANSPACH INSTRUMENT CADDY | The Anspach Effort, Inc. | 1980-06-09 | Traditional | PDF ↗ |
| K800275 | CEBOTOME DRILL | American Sterilizer Co. | 1980-02-19 | Traditional | PDF ↗ |
| K791056 | 3M CEMENT REMOVER | 3M Company | 1979-07-30 | Traditional | PDF ↗ |
| K790645 | ENDOTOME | Berkeley Bio-Engineering | 1979-04-23 | Traditional | PDF ↗ |
| K781979 | SURGAIRTOME TWO | American Sterilizer Co. | 1978-12-20 | Traditional | PDF ↗ |
| K780139 | PNEUMATIC POWERED BUR | North Palm Beach Orthodepic Assoc. | 1978-02-01 | Traditional | PDF ↗ |
| K772324 | WIREDRIVER | American Sterilizer Co. | 1978-01-03 | Traditional | PDF ↗ |
Product code HSZ · Class I · General, Plastic Surgery. Data: openFDA.