510(k) K002605
- Device
- 4.0/2.5 MM SELF-DRILLING SCHANZ SCREW
- Applicant
- SYNTHES (USA)
- 510(k) number
- K002605
- Product code
- JDW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2000-11-20
- Date received
- 2000-08-22
- 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
- BONNIE J SMITH
- Address
- 1690 Russell Rd. Paoli PA US 19301 19301
FDA Registration Numbers#
- 3010667733
- 1720929
- 3034676720
- 2183946
- 1221934
- 3004176895
- 3025603301
- 3015709929
- 3007993775
- 3008812251
- 9611274
- 1043534
- 1220477
- 2245304
- 3030966822
- 3010220595
- 3008114965
- 3009732568
- 1220246
- 3021008900
- 3042903229
- 3011500362
- 1833506
- 3004983210
- 1424434
- 3033536312
- 2031910
- 1219930
- 3010673850
- 1051526
- 3009116370
- 3015440604
- 3006849754
- 3014967969
- 3011683674
- 3004893332
- 3005809810
- 3009756327
- 3014315560
- 1057425
- 1020279
- 1060840
- 1835831
- 3006946279
- 2244478
- 3011137372
- 3001239363
- 3015231789
- 3007051929
- 3006460162
- 1000517406
- 1818910
- 3014315669
- 9680619
- 3004369035
- 3010178296
- 3017406274
- 3006395932
- 3004358587
- 1643264
- 1225838
- 3005180920
- 3010173425
- 1833920
- 3010041430
- 3031240334
- 8043862
- 2431166
- 3003249380
- 3007353762
- 3014302784
- 3010536692
- 3010155648
- 3007923096
- 3004748528
- 3007366790
- 3006513362
- 3010470577
- 3036756245
- 1226544
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#
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FDA Review#
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