510(k) K931037
- Device
- Whitmore Vacuum-lock Spinal Frame (vlsf-100)
- Applicant
- WHITMORE ENT., INC.
- 510(k) number
- K931037
- Product code
- FWZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1993-07-30
- Date received
- 1993-03-01
- Regulation
- 878.4950
- Classification name
- Operating Room Accessories Table Tray
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- EARL HARMSEN
- Address
- Rt. 5 Box 369 San Antonio TX US 78221 78221
FDA Registration Numbers#
- 3010373530
- 3012345110
- 3027339877
- 3012281713
- 1824206
- 3005440795
- 3004414785
- 3006535925
- 2182536
- 1220246
- 3032391
- 3014383485
- 1320894
- 3009888344
- 3010595915
- 3006400329
- 3004905643
- 3011230048
- 3006787036
- 3005595283
- 9680168
- 3006654680
- 3021226419
- 1647149
- 3004361359
- 1218386
- 3001650535
- 9710524
- 3004491689
- 2242450
- 2028805
- 3007137643
- 3005285078
- 3012708860
- 1526534
- 2248030
- 3003418325
- 1032347
- 1055236
- 9616088
- 3017410889
- 1037885
- 3012595397
- 3014623126
- 3037012186
- 1000655158
- 2032003
- 3011824442
- 3007307488
- 3008314176
- 3045857302
- 1421879
- 1061124
- 1043214
- 3007886583
- 1018470
- 1223419
- 3009009512
- 3023339277
- 2916714
- 3005438755
- 2921578
- 1060680
- 3011137372
- 3015531959
- 3010452421
- 3015425095
- 2183449
- 3010060157
- 2518414
- 2084346
- 2126670
- 1643817
- 3006538822
- 2031917
- 9614209
- 9616086
- 1417592
- 3016851379
- 3004111573
Source Documents#
Other 510(k) Records For Product Code FWZ#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K960019 | RETRACTOR ARM CLAMP | Biopsys Medical, Inc. | 1996-02-09 |
| K945415 | 'LIL MAC ACCESSORY CLAMP(TM) | D.L. Nelson and Assoc., Inc. | 1994-11-22 |
| K944779 | CARBON LIGHTS HAND SURGERY TABLE | Allen Medical Systems, Inc. | 1994-10-14 |
| K935381 | KAPS POSITIONING ARM | Andronic Devices, Ltd. | 1994-04-15 |
| K926225 | SPONGE COUNTER | American Medical Manufacturer, Inc. | 1993-03-05 |
| K925035 | MIDKIFF GEOSTATIC CLAMP | D.L. Nelson and Assoc., Inc. | 1993-02-18 |
| K905564 | PREP AND OPERATING STAND | Mcconnell Orthopedic | 1991-02-21 |
| K905565 | LATERAL BUTTRESS SUPPORT | Mcconnell Orthopedic | 1991-02-21 |
| K910031 | PARK CITY SHOULDER POSITIONER | Orthopedic Systems, Inc. | 1991-01-24 |
| K904826 | TKO TELESCOPING LITHOTOMY STIRRUP | D.L. Nelson and Assoc., Inc. | 1990-10-31 |
| K897028 | LINCOLN MILLS FOOT AND LEG HOLDER | Lincoln Mills, Inc. | 1990-01-12 |
| K890501 | SECOND ASSISTANT | 3M Company | 1989-02-10 |
| K885215 | LINCOLN MILLS HIP HOLDER | Lincoln Mills, Inc. | 1989-01-13 |
| K884928 | FREE ARM(TM) | Faro Medical Technologies, Inc. | 1988-12-15 |
| K882078 | SPINAL SURGERY FRAME | Karlin Technology, Inc. | 1988-06-16 |