510(k) K960711
- Device
- ACUMED BONE GRAFT SYSTEM
- Applicant
- ACUMED, INC.
- 510(k) number
- K960711
- Product code
- KIJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1996-05-07
- Date received
- 1996-02-21
- Regulation
- 878.4820
- Classification name
- Instrument, Surgical, Orthopedic, Dc-powered Motor And 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
- SHARI L JEFFERS
- Address
- 10950 SW 5th St. Suite 170 Beaverton OR US 97005 97005
FDA Registration Numbers#
- 3014747863
- 3037012186
- 2029275
- 3034669683
- 3013756169
- 1423662
- 3025436467
- 3007123908
- 1422572
- 3033509898
- 2020601
- 3017196117
- 3007997036
- 3009971621
- 1043653
- 3007344102
- 2028632
- 3043620689
- 3008951116
- 9616671
- 1818910
- 3006460162
- 1220477
- 3011530718
- 3010703925
- 3016112537
- 3025141
- 1226544
- 3007539489
- 3030966822
- 1221934
- 1649518
- 2135156
- 1526534
- 3025603301
- 3013422236
- 3015967359
- 3004719693
- 3020155054
- 1835831
- 3010373263
- 1057946
- 1834379
- 1835296
- 3004049923
- 2916714
- 1834331
- 3029826185
- 3008590661
- 3008709738
- 3008793310
- 1643264
- 3004217743
- 2032098
- 3007958831
- 3010045785
- 3030427687
- 1720929
- 3036756245
- 3012764194
- 3007084590
- 1835251
- 2132111
- 2027754
- 3009106092
- 3034932459
- 3007441485
- 1000517406
- 3009599228
- 9610905
- 3007125392
- 3017181414
- 1531174
- 3015151147
- 3015516266
- 3003604053
- 1219602
- 3009973699
- 3019932374
Source Documents#
Other 510(k) Records For Product Code KIJ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K163308 | SMARTO | Jeil Medical Corporation | 2016-12-27 |
| K112599 | INSURGICAL SINGLE USE POWER EQUIPMENT | Insurgical, LLC | 2012-11-06 |
| K101563 | SMARTO | Jeil Medical Corporation | 2010-12-17 |
| K972367 | STRYKER SYSTEM 4000 HEAVY DUTY BATTERY POWERED EQUIPMENT | Stryker Instruments | 1997-09-04 |
| K970378 | STRYKER 2115 REPLACEMENT BATTERY (2115) | Implant Resource, Inc. | 1997-04-30 |
| K951450 | SYSTEM 2000 REPLACEMENT BATTERY, SYSTEM 2000-EXTENDED RUN REPLACEMENT BATTERY | Strenumed, Inc. | 1995-05-17 |
| K944488 | S & S ORTHOPEDIC WIRE DRIVER 701 | S & S Orthopedic , Ltd. | 1995-03-02 |
| K941285 | ARTHREX GRAFT HARVESTING KIT | Arthrex, Inc. | 1994-11-14 |
| K933101 | THE OSTEOMED B POWER SYSTEM AND ACCESSORIES | Osteomed Corp. | 1994-11-07 |
| K933337 | R AND D BATTERY REPLACEMENT | R & D Batteries, Inc. | 1994-04-05 |
| K931395 | SERIES 5000 BATTERY POWERED INSTRUMENT SYSTEM | Micro Surgical Instruments Corp. | 1994-01-28 |
| K932307 | 3M MAXI-DRIVER II DBATTERY POWERED SYSTEM | 3M Health Care, Ltd. | 1994-01-07 |
| K884839 | MODIFIED SAW BLADES TO THE SAGITAL SAW | Dyonics, Inc. | 1988-12-07 |
| K873766 | STERNAL POWER AWL | Bowen & Company, Inc. | 1988-11-14 |
| K864137 | LYPHOCHEK IMMUNOASSAY SERUM CONTROL LEVEL I,II,III | Bio-Rad | 1986-11-07 |
Legacy Summary#
summary
FDA Review#
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