510(k) K820612
- Device
- Tensoplast Skin Traction Kit
- Applicant
- SMITH & NEPHEW, INC.
- 510(k) number
- K820612
- Product code
- HST
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1982-03-31
- Date received
- 1982-03-08
- Regulation
- 888.5850
- Classification name
- Apparatus, Traction, Non-Powered
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- 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#
- 3014262693
- 3006038729
- 3017413568
- 1000328618
- 3006128100
- 3021313801
- 8010769
- 3012404688
- 3013564718
- 3016159364
- 3011171243
- 3006563279
- 2921578
- 3005621808
- 3007076137
- 1644243
- 3013404959
- 3005246958
- 3015429713
- 3015974593
- 3042194239
- 3009641282
- 1511629
- 3034694939
- 9616877
- 3013700547
- 3007305485
- 3016851379
- 3009759525
- 3014982318
- 3019269298
- 3010400367
- 2087341
- 3014004349
- 3005885000
- 9613910
- 1833053
- 2936485
- 3005706637
- 3012883081
- 3010331645
- 3010394125
- 3023187489
- 3008048783
- 3010123014
- 9617426
- 3034729907
- 3015543909
- 3007420694
- 2510425
- 8010100
- 3012470322
- 2031966
- 9680168
- 3008724689
- 3005282622
- 8040255
- 2432177
- 3010182295
- 3008008970
- 3011508500
- 3010605276
- 1818910
- 2531195
- 3027339877
- 3005061536
- 3015231789
- 3008812560
- 3012191412
- 3007731000
- 3025141
- 9616086
- 3009417901
- 3006697241
- 1020279
- 3033536312
- 3010675856
- 3009257854
- 3006654680
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code HST#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K162702 | Teeter Manual Inversion Table; Teeter Gravity Boots; Teeter Forward Rotation Decompression Device; Teeter Portable Decompression Device; Teeter Horizontal Decompression Table | Stl International, Inc. | 2016-12-30 |
| K110858 | LO-BAK TRAX | Roland F Berthiaume, DC | 2011-08-02 |
| K984190 | BACK-ON-TRAC, MODEL 101BOT | Back-On-Track, Inc. | 1999-03-15 |
| K872121 | K AND D HOME TRACT | Joseph A. Kott, M.D. | 1987-08-12 |
| K870212 | ARTHROSCOPIC SHOULDER HOLDER | Dyonics, Inc. | 1987-02-20 |
| K870125 | EXTREMITY ELEVATOR | Orthopedic Systems, Inc. | 1987-02-04 |
| K870102 | TUPPER TROLLEY | Orthopedic Systems, Inc. | 1987-02-03 |
| K864765 | MODEL 668, TRACTION SPLINT, ADULT | Ferno-Washington, Inc. | 1986-12-17 |
| K862874 | THE TOWERED 90/90 UNIT | Lossing Orthopedic, Inc. | 1986-08-07 |
| K860037 | SUSPENDER ORTHOPEDIC SUSPENSION DEVICE | Comfortex, Inc. | 1986-01-21 |
| K855179 | TRANSFER-TRAX (TM) SPLINT TRACTION | Comfortex, Inc. | 1986-01-21 |
| K844239 | NEC-KRADLE BY VENCOR | Vencor | 1984-11-19 |
| K841388 | ACUFEX SHOULDER HOLDER | Acufex Microsurgical, Inc. | 1984-05-16 |
| K841368 | HYPERBARIC OXYGEN GURNEY- | Orthopedic Systems, Inc. | 1984-05-16 |
| K831888 | COMPUTERIZED TOMOGRAPHY-HYPERBARIC OXYG | Portable Travtion Device Co. | 1983-07-12 |