510(k) K771988
- Device
- Vertetrac
- Applicant
- BALLERT ORTHOPEDIC CORP.
- 510(k) number
- K771988
- Product code
- HST
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1979-02-01
- Date received
- 1977-10-19
- 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#
- 3022192
- 3020978012
- 3015974593
- 3023187489
- 3010605276
- 1824206
- 3004464325
- 3031170295
- 3015399803
- 1020279
- 3016734231
- 3005061536
- 1000604079
- 3013404959
- 1043534
- 3014004349
- 3010703418
- 3020155054
- 9617426
- 9680168
- 3005906953
- 3007731000
- 8010769
- 3012329552
- 3003973936
- 3008008970
- 3012316249
- 3007305485
- 3006453790
- 3012818475
- 3010659131
- 3012267976
- 2242467
- 1223421
- 3010198795
- 3005706637
- 3007222468
- 3014680784
- 3006697241
- 3016727307
- 3013700547
- 3010400367
- 8030607
- 3005273623
- 1643817
- 3007648354
- 3013374101
- 3021313801
- 3003890514
- 1017294
- 1058584
- 3010675856
- 3014301546
- 2936485
- 3015277818
- 1041130
- 1422443
- 3005246958
- 3013070831
- 3007076137
- 3004012851
- 3034676720
- 3005033444
- 2132732
- 3010310816
- 2030775
- 1043214
- 9616877
- 1061927
- 1818910
- 3006563279
- 1000328618
- 3009251316
- 2531232
- 3012404688
- 3004755235
- 3021336182
- 3043127556
- 3011230048
- 3010595915
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 |
| K855179 | TRANSFER-TRAX (TM) SPLINT TRACTION | Comfortex, Inc. | 1986-01-21 |
| K860037 | SUSPENDER ORTHOPEDIC SUSPENSION DEVICE | Comfortex, Inc. | 1986-01-21 |
| K844239 | NEC-KRADLE BY VENCOR | Vencor | 1984-11-19 |
| K841368 | HYPERBARIC OXYGEN GURNEY- | Orthopedic Systems, Inc. | 1984-05-16 |
| K841388 | ACUFEX SHOULDER HOLDER | Acufex Microsurgical, Inc. | 1984-05-16 |
| K831888 | COMPUTERIZED TOMOGRAPHY-HYPERBARIC OXYG | Portable Travtion Device Co. | 1983-07-12 |