510(k) K970345
- Device
- ALIGNMENT INSTRUMENT
- Applicant
- RICHARD WOLF MEDICAL INSTRUMENTS CORP.
- 510(k) number
- K970345
- Product code
- HSZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-04-29
- Date received
- 1997-01-29
- Regulation
- 878.4820
- Classification name
- Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/attachment
- Medical specialty
- General & Plastic Surgery
- Review panel
- Orthopedic
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- ROBERT L CASARSA
- Address
- 353 Corporate Woods Pkwy. Vernon Hills IL US 60061 60061
FDA Registration Numbers#
- 1058584
- 3000270450
- 3007366790
- 1038671
- 3009812190
- 1047843
- 3038503932
- 1625507
- 1045254
- 3015967359
- 3010202439
- 3009227834
- 1649518
- 3005382983
- 1825034
- 1061124
- 9611102
- 2020550
- 1833986
- 3004464325
- 1836161
- 3013176080
- 3042243169
- 3002807310
- 3015440604
- 2647346
- 2025102
- 3008951116
- 3015207155
- 1020279
- 2029275
- 3008868758
- 3035366890
- 1000200989
- 1954316
- 3009417901
- 2183911
- 1834331
- 2244478
- 3018094310
- 1045834
- 1226544
- 3008812560
- 3036756245
- 3013011598
- 3017196117
- 3007997036
- 3015882686
- 1526534
- 1017294
- 3009106092
- 3014479313
- 8030607
- 3025603301
- 3031240334
- 2648666
- 3033509898
- 1822565
- 3016172274
- 1828464
- 3015399803
- 3005061536
- 3020155054
- 3008808049
- 3008744062
Source Documents#
Other 510(k) Records For Product Code HSZ #
| 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 |
| 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 |
Legacy Summary#
summary
FDA Review#
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