510(k) K863415
- Device
- RAYLOR BONE IMPACTORS
- Applicant
- CEDAR SURGICAL, INC.
- 510(k) number
- K863415
- Product code
- HAO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1986-09-24
- Date received
- 1986-09-03
- Regulation
- 882.4535
- Classification name
- Instrument, Surgical, Non-powered
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- TERRY P CORBIN
- Address
- 15265 Minnetonka Blvd. Minnetonka MN US 55345 55345
FDA Registration Numbers#
- 1833920
- 8010395
- 2132732
- 2182207
- 9710524
- 3007773213
- 1000517406
- 9610905
- 3005061536
- 8010298
- 2183456
- 3006487092
- 2529846
- 3003923584
- 3014334038
- 1644408
- 3012995405
- 1047843
- 2183744
- 8010591
- 3010646402
- 3003418325
- 9611278
- 3026820968
- 9617544
- 9616088
- 9614986
- 9614062
- 3006765019
- 3017435639
- 3014342096
- 1319639
- 3028006458
- 2182979
- 3009420598
- 9611502
- 1644487
- 8010386
- 3013784566
- 3010687973
- 1054811
- 3004024955
- 3008902714
- 3036795921
- 3007137643
- 3009822485
- 3006247277
- 3006546082
- 9611461
- 9680518
- 3011547624
- 8010665
- 9680002
- 3004571672
- 3008285983
- 1723170
- 3002807295
- 1057946
- 3005067367
- 1424478
- 3002834291
- 9611262
- 1646747
- 3007507973
- 1423537
- 3010707607
- 1416891
- 3030516433
- 9612278
- 9680515
- 1219653
- 3000286616
- 8010877
- 2916714
- 3007666314
- 3012447612
- 3002250546
- 8010177
- 3004361445
- 8040233
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code HAO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K220920 | Matreneu Percutaneous Balloon Compression Kit | Shenzhen Shineyard Medical Device Co. , Ltd. | 2022-09-07 |
| K940973 | MULLAN GANGLION MICROCOMPRESSION SET | Cook, Inc. | 1995-09-29 |
| K951492 | RIB RESECTOR | United States Surgical, A Division of Tyco Healthc | 1995-05-18 |
| K943115 | AUTO SUTURE PITUITARY SPINAL RONGEUR | United States Surgical, A Division of Tyco Healthc | 1994-07-25 |
| K942967 | AUTO SUTURE SPINAL CURETTE | United States Surgical, A Division of Tyco Healthc | 1994-07-20 |
| K942968 | AUTO SUTURE SPINAL OSTEOTOME | United States Surgical, A Division of Tyco Healthc | 1994-07-20 |
| K942969 | AUTO SUTURE SPINAL NERVE HOOK | United States Surgical, A Division of Tyco Healthc | 1994-07-20 |
| K942970 | AUTO SUTURE SPINAL ELEVATOR | United States Surgical, A Division of Tyco Healthc | 1994-07-20 |
| K942971 | AUTO SUTURE SPINAL DISSECTOR | United States Surgical, A Division of Tyco Healthc | 1994-07-20 |
| K923723 | SILICONE BRAIN SPATULA SET | Redmond Neurosurgical, Inc. | 1992-08-12 |
| K910225 | BONE PAD REMOVER | Acra Cut, Inc. | 1991-02-12 |
| K910226 | DURAL DISSECTORS | Acra Cut, Inc. | 1991-02-12 |
| K902850 | ZEPPELIN INSTRUMENTS | Ruggles Corp. | 1990-07-18 |
| K892546 | TAYLOR SPINAL RETRACTOR | Zinnanti Surgical Instruments, Inc. | 1989-05-11 |
| K882422 | DISPOSABLE ARACHNOID KNIFE | Microbio-Medics, Inc. | 1988-09-06 |
Legacy Summary#
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FDA Review#
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