510(k) K832899
- Device
- Zimmer Ossimeter
- Applicant
- ZIMMER, INC.
- 510(k) number
- K832899
- Product code
- FTY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1983-10-14
- Date received
- 1983-08-29
- Regulation
- 878.4800
- Classification name
- Tape, Measuring, Rulers And Calipers
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3004824601
- 3010237768
- 9611502
- 2084346
- 2320762
- 3014763043
- 3006487092
- 3012179728
- 3014615697
- 8010099
- 3002769835
- 9616088
- 3015451828
- 3007366790
- 3009134882
- 3005641619
- 2249697
- 3009051471
- 9611450
- 3003597504
- 9610612
- 3006400329
- 3000286616
- 3011371465
- 3003644849
- 1030451
- 2134812
- 3006210673
- 3004571972
- 2132732
- 2183650
- 3010287737
- 2431166
- 3011693567
- 3007344102
- 3010097171
- 3004784004
- 3010667733
- 3015876273
- 3003761012
- 3032109
- 3002719998
- 3002808270
- 3036795921
- 3009973336
- 3007074192
- 2086043
- 1836161
- 2183744
- 3013846070
- 3035366890
- 3003812504
- 3026222938
- 3005809810
- 9611283
- 3011137372
- 1833053
- 9680518
- 2433012
- 3010065126
- 3033536312
- 2518436
- 8010372
- 1828288
- 3004742232
- 3009488612
- 3008352964
- 3003039352
- 2183456
- 2432177
- 3002949614
- 8043554
- 3006460162
- 1421101
- 9680519
- 1937137
- 3015212339
- 3007125392
- 3007031057
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FTY#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K160501 | Noxilizer Surgical Ruler | Noxilizer, Inc. | 2016-05-26 |
| K951064 | DISPOSABLE WOUND MEASURE GUIDE, PLASTIC, PROTECTOR, WOUND, PLASTIC | S-E Sales & Distribution, Inc. | 1995-05-19 |
| K934930 | OLYMPIC AUTO-LENGTH | Olympic Medical Corp. | 1993-12-29 |
| K932112 | OLYMPIC INFA-LENGTH | Olympic Medical Corp. | 1993-07-22 |
| K883485 | STRYKER PRESSURE MONITOR SYSTEM | Stryker Corp. | 1988-09-13 |
| K880441 | PEDIATRIC AIRWAY MEASUREMENT SYSTEM & P.A.M.S. | Plane Iii, Inc. | 1988-02-18 |
| K874352 | TUMORIMETER | Cancer Technologies, Inc. | 1987-11-23 |
| K873470 | TEMPLATE | Cox-Uphuff Intl. | 1987-09-08 |
| K872319 | LN 100 BREAST MARKER | Instrumentation Industries, Inc. | 1987-08-11 |
| K863409 | KUNDIN WOUND GAUGE | Jane I. Kundin | 1986-09-29 |
| K862576 | PS2 BRAND FACIAL SYMMETRY GUIDE (LEE DESIGN) | Professional Services For Surgeons, Ltd. | 1986-07-15 |
| K860912 | PS2 BRAND MAMMAPLASTY | Professional Services For Surgeons, Ltd. | 1986-03-24 |
| K854892 | RULER | Euro-Med Intl. | 1985-12-24 |
| K840651 | MOLE-MARKER | Notation Systems, Inc. | 1984-03-12 |
| K831041 | SAGITTAL KNEE TESTER | Orthopedic Systems, Inc. | 1983-06-24 |