510(k) K892546
- Device
- TAYLOR SPINAL RETRACTOR
- Applicant
- ZINNANTI SURGICAL INSTRUMENTS, INC.
- 510(k) number
- K892546
- Product code
- HAO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1989-05-11
- Date received
- 1989-04-11
- 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
- ANNA STRAIGHT
- Address
- 21540-B Prairie St. Chatsworth CA US 91311 91311
FDA Registration Numbers#
- 2183449
- 9617544
- 9614062
- 3009865268
- 9610905
- 3015967359
- 3008338766
- 3002250546
- 9611815
- 1421101
- 1211566
- 9612075
- 9611502
- 1836161
- 8010697
- 3006487092
- 3007648354
- 3013886523
- 8010303
- 9680242
- 3004571672
- 3007636029
- 3028006458
- 3010757045
- 8010177
- 3002807090
- 3026820968
- 2433012
- 2134947
- 3005621335
- 3016050940
- 3042278955
- 1056350
- 3008902714
- 1416891
- 3003477135
- 8010168
- 9614084
- 8040278
- 1219653
- 9617426
- 3010687973
- 1935627
- 1220477
- 3005061536
- 8010298
- 8010547
- 1221763
- 3004111573
- 2183456
- 1220724
- 3006546082
- 3008285983
- 3012447612
- 3009420598
- 3009513193
- 1923569
- 3004450489
- 3005440795
- 3015546200
- 8010386
- 3007507973
- 2020550
- 3005067367
- 3004024955
- 3021453307
- 3003923584
- 2183744
- 3007456622
- 9680002
- 1319639
- 2182979
- 3013784566
- 3007773213
- 1820334
- 9611283
- 1421879
- 3010052483
- 8010405
- 9611112
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 |
| K882422 | DISPOSABLE ARACHNOID KNIFE | Microbio-Medics, Inc. | 1988-09-06 |
| K880278 | MALLEABLE PTFE COATED BRAIN SPATULAE | Downs Surgical , Ltd. | 1988-02-11 |
Legacy Summary#
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FDA Review#
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