Atlas FDA

HSZ

56 FDA 510(k) clearances · Product code

52 daysmedian time to decision
234 days90th percentile
56clearances measured

FDA profile

Official device name
Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment
Device class
Class I (low risk)
Regulation
21 CFR 878.4820
Medical specialty
General, Plastic Surgery
Adverse events (MAUDE)
2017: 24 · 2018: 13 · 2020: 13 · 2021: 27 · 2022: 35 · 2023: 39
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
EMS SWISS ORTHOCLAST (K991588)(Ems Sa) Electro Medical Systems1999-07-21
CURVTEK TSR SYSTEM (K972860)Biolectron, Inc.1997-10-31
ALIGNMENT INSTRUMENT (K970345)Richard Wolf Medical Instruments Corp.1997-04-29
ASPACH 65,000 (MODIFICATION) (K955084)The Anspach Effort, Inc.1996-01-17
SODEM HIGH SPEED SYSTEM (K954080)Sodem Diffusion SA1995-10-16
ETHICON DRILL BIT AND DRILL GUIDE (K944590)ETHICON, Inc.1995-05-11
SPINALPLANE (K934336)Synvasive Technology, Inc.1995-03-10
FILTER, DIFFUSER (K940276)Anspach Mfg., Inc.1994-11-16
PNEUMATIC WIRE TENSIONER (K942760)Smith & Nephew Richards, Inc.1994-09-06
ARTHREX CIRCULAR HARVESTING SAW (K941681)Arthrex, Inc.1994-08-25
TAVA WIRE-DRIVER (K935367)Tava Surgical Instruments1994-04-21
PNEUMATIC WIRE TENSIONER (K934431)Smith & Nephew Richards, Inc.1994-01-27
THE DE SOUTTER M182 DRILL (K930785)De Soutter Medical, Ltd.1993-10-27
THE DE SOUTTER M193 REAMER (K930784)De Soutter Medical, Ltd.1993-10-27
MEDNEXT 1000 BONE DISSECTING SYSTEM (K926547)Mednext, Inc.1993-07-22
HHI PNEUMATIC ROTARY DRILL (K922661)H&H Instruments1992-09-18
MODEL 2250-000 ZIMMER STYLE SAGITTAL SAW MODULE (K915139)Micro Surgical Instruments Corp.1992-02-05
M170 PNEUMATICALLY OPERATED OSCILLATING SAW (K914845)Desutter Medical , Ltd.1992-01-13
JOHNSON AND JOHNSON POWER SYSTEM (K913629)Johnson & Johnson Orthopaedics, Inc.1991-11-13
OSTEO COMPLETE PNEUMATIC DRILL-OSCILAIR (K913559)Osteo AG1991-11-07
CUP OUT (K905027)Anspach Mfg., Inc.1991-02-05
MICRO-AIRE 4220-000 OSCILLATING SAW (K905277)Micro Surgical Instruments Corp.1991-01-08
BONE RASPS (K905187)Micro Surgical Instruments Corp.1990-12-19
A.O. SYNTHES,TAP(REPLACEMENT)VARIOUS MODEL NUMBERS (K904949)Micro-Aire Surgical Instruments, Inc.1990-11-26
OSTEOTOME MODEL NUMBERS 2500-228 & 2500-229 (K903713)Micro-Aire Surgical Instruments, Inc.1990-09-14
THE KIRSCHNER UNIVERSAL POWER TOOL SYSTEM (K901455)Kirschner Medical Corp.1990-05-14
BONE HARVESTER SYSTEM & OSTEOTOME SYSTEM 2500 (K900210)Micro-Aire Surgical Instruments, Inc.1990-02-02
MODIFIED GLENOID ARCUATE DRILL & DISP. FLEXI-BITS (K885229)Romano Surgical Instrumentation, Inc.1989-09-29
INTERMEDICS POWER BROACH IMPACTOR (K895121)Intermedics Orthopedics1989-09-11
MICRO SURGICAL INSTRUMENT SYSTEM (K885273)Tava Surgical Instruments1989-01-30
MICRO SURGICAL INSTRUMENT SYSTEM (K884492)Tava Surgical Instruments1988-11-16
CONCEPT POWER SYSTEM (K881954)Concept, Inc.1988-11-09
ARTUS DISPOSABLE SHEATHS/CUTTERS (K880881)Acufex Microsurgical, Inc.1988-05-04
ACE PNEUMATIC OSCILLATING SAW (K881250)Buckman Co., Inc.1988-04-15
RSI GLENOID ARCUATE BONE DRILL W/DISP. FLEXI-BITS (K880074)Romano Surgical Instrumentation, Inc.1988-03-25
MICRO-AIRE CEMENT REMOVAL TOOLS (K880324)Micro-Aire Surgical Instruments, Inc.1988-02-17
1.1 COUPLERS AND 1.2 ADAPTERS (K872550)Micro-Aire Surgical Instruments, Inc.1987-07-21
KARL STORZ MODEL 28184 PNEUMATIC SHUTTLE SHAVER (K871891)KARL STORZ Endoscopy-America, Inc.1987-06-05
ORTHOPEDIC DRILL GUIDE (K871287)Orthopedic Systems, Inc.1987-04-15
EFTEKHAR RECHANNELIZATION DRILL GUIDE (K864314)The Anspach Effort, Inc.1986-11-19
REPLACEMENT HOSES (K861405)Micro-Aire Surgical Instruments, Inc.1986-04-25
MICRO-AIRE OSCILLATING SAW, 1740-000 & WIRE DRIVER (K851443)Micro-Aire Surgical Instruments, Inc.1985-05-03
ACUFEX ARTHROSCOPIC SHAVER (K844130)Acufex Microsurgical, Inc.1985-03-21
NUCLEOTOME (K844131)Medical Instrument Development Laboratories, Inc.1984-11-29
ENDOTOME PNEUMATIC ORTHOPAEDIC CUT (K840831)Cabot Medical Corp.1984-04-04
ANSPACH 65,000 (K831756)The Anspach Effort, Inc.1983-09-29
MICRO OSCILLATING SAW (K811834)Micro-Aire Surgical Instruments, Inc.1981-07-20
CORB TM COUNTERROTATING BIOPSY NEEDLE (K811005)Zimmer, Inc.1981-06-15
OSTEO OSCILAIR (K803284)Richard'S Medical Equip., Inc.1981-01-09
ANSPACH INSTRUMENT CADDY (K801329)The Anspach Effort, Inc.1980-06-09
CEBOTOME DRILL (K800275)American Sterilizer Co.1980-02-19
3M CEMENT REMOVER (K791056)3M Company1979-07-30
ENDOTOME (K790645)Berkeley Bio-Engineering1979-04-23
SURGAIRTOME TWO (K781979)American Sterilizer Co.1978-12-20
PNEUMATIC POWERED BUR (K780139)North Palm Beach Orthodepic Assoc.1978-02-01
WIREDRIVER (K772324)American Sterilizer Co.1978-01-03

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Every clearance here is in the API, with alerts when new ones post.