510(k) K963433
- Device
- THREADED FIXATION PIN
- Applicant
- ORTHOPAEDIC BIOSYSTEMS, LTD.
- 510(k) number
- K963433
- Product code
- JDW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1996-11-06
- Date received
- 1996-08-30
- Regulation
- 888.3040
- Classification name
- Pin, Fixation, Threaded
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JEFFRY B SKIBA
- Address
- 7320 E. Butherus Suite 206 Scotsdale AZ US 85260 85260
FDA Registration Numbers#
- 2648623
- 3031240334
- 3007353762
- 3013011598
- 1526439
- 9611274
- 3010470577
- 2249615
- 9680619
- 3011500362
- 3018269629
- 3014302784
- 1424434
- 3011137372
- 1226544
- 3015440604
- 3001239363
- 2245304
- 1043534
- 3033509898
- 8010468
- 3025603301
- 3004748528
- 1828288
- 3016496998
- 3034676720
- 3004215117
- 3010331645
- 3005809810
- 3005061536
- 1526534
- 1833920
- 3010123172
- 3042903229
- 3011277306
- 1225838
- 2249529
- 3006694268
- 3009882462
- 3006849754
- 3006017180
- 1833986
- 3006513362
- 3009973505
- 3004893332
- 2919128
- 8010916
- 3003108161
- 9680825
- 3015895045
- 1220246
- 2183449
- 3019356409
- 3015399803
- 1720929
- 3015542154
- 3006946279
- 3010407203
- 3014522470
- 1219930
- 3004369035
- 3007887127
- 3010173425
- 1018470
- 3017406274
- 3009417901
- 1835251
- 3007130914
- 1057425
- 3008110533
- 3011683674
- 3008114965
- 3008534770
- 3006783837
- 1226074
- 2134947
- 3000270450
- 1528668
- 3010041499
- 3013176080
Source Documents#
Other 510(k) Records For Product Code JDW #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260073 | XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mm | Biodynamik, Inc. | 2026-02-10 |
| K250316 | Meduloc Intramedullary Fracture Fixation (IFF) System | Meduloc, LLC | 2025-10-29 |
| K241357 | XT3 System | Biodynamik, Inc. | 2025-01-22 |
| K223112 | MAVERICK Mini External Fixation System | Smith & Nephew, Inc. | 2022-12-08 |
| K213874 | MAVERICK External Fixation System | Smith & Nephew, Inc. | 2022-02-11 |
| K211508 | Steinmann Pins and Kirschner Wires | Stryker GmbH | 2021-10-05 |
| K210784 | Extended HA Half Pins | Smith & Nephew, Inc. | 2021-04-02 |
| K200933 | Syntec Non-Sterile Steinmann Pins System | Syntec Scientific Corporation | 2020-05-05 |
| K191803 | Orthopedic Fixation Pin | Tinavi (Anhui) Medical Technologies Co., Ltd. | 2020-04-14 |
| K192768 | Temporary Fixation Pins | Eisertech, LLC | 2019-12-26 |
| K182171 | SMV Scientific K-Wire and Pins | Summit Medventures | 2018-10-25 |
| K163487 | Ultima HA Coated Half Pins and Wire | Vilex IN Tennessee, Inc. | 2017-02-13 |
| K150661 | ST.A.R. 90 F4 External Fixation Screws With Hydroxyapatite | Citieffe S.R.L. | 2015-07-07 |
| K132820 | VILEX ULTIMA EXTERNAL FIXATION SYSTEM WITH HA COATED PINS AND WIRES | Vilex, Inc. | 2014-07-23 |
| K140875 | OPTOSSOL COMPRESSION DEVICE SYSTEM | Genossis, LLC | 2014-05-30 |
Legacy Summary#
summary
FDA Review#
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