510(k) K992970
- Device
- DIGIT WIDGET
- Applicant
- HAND BIOMECHANICS LAB, INC.
- 510(k) number
- K992970
- Product code
- JDW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1999-11-08
- Date received
- 1999-09-03
- 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
- JOHN M AGEE
- Address
- 77 Scripps Dr., Suite 104 Sacramento CA US 95825 95825
FDA Registration Numbers#
- 3030966822
- 3008868758
- 1822565
- 1057425
- 8043792
- 3013011598
- 3014302784
- 3021008900
- 1720747
- 3011656326
- 3010123172
- 1835572
- 1226544
- 1528668
- 3007366790
- 3007051929
- 3006801265
- 3025141
- 3005180920
- 3007125392
- 2244478
- 3015212339
- 3007993775
- 1225838
- 3014522470
- 3010155648
- 3008114965
- 3015216945
- 3010065126
- 3004976965
- 3011137372
- 3005641619
- 3033509898
- 3008812560
- 3006017180
- 2936485
- 3010470577
- 3010667733
- 3001239363
- 2919128
- 3015869121
- 3006694268
- 3003249380
- 1833986
- 3011295718
- 3009732568
- 1835831
- 3012770122
- 3018269629
- 8043862
- 3036756245
- 3034676720
- 1424434
- 1018470
- 9615765
- 8031020
- 3010041499
- 3006395932
- 3013540005
- 3011301313
- 3015207155
- 1828288
- 3010178296
- 3009888740
- 3042903229
- 3009116370
- 3033536312
- 3009756327
- 3014315560
- 3002807315
- 3009882462
- 1825034
- 3014967969
- 2134947
- 3011277306
- 3002907620
- 2183946
- 2031910
- 1421101
- 3004358587
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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