510(k) K033252
- Device
- MODIFICATION TO STRYKER BIOABSORBABLE INTERFERENCE SCREW SYSTEM
- Applicant
- Stryker Endoscopy
- 510(k) number
- K033252
- Product code
- HWC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2003-11-13
- Date received
- 2003-10-08
- Regulation
- 888.3040
- Classification name
- Screw, Fixation, Bone
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- MELISSA MURPHY
- Address
- 5900 Optical Ct. San Jose CA US 95138 95138
FDA Registration Numbers#
- 2183449
- 3012491394
- 2183946
- 3010123172
- 3009973699
- 2531195
- 3030514683
- 3009871135
- 3012470322
- 1834379
- 1833506
- 3035785605
- 3014262693
- 9612277
- 3012818475
- 3030714745
- 1526534
- 3009971621
- 3010400367
- 3011302058
- 3004464325
- 3038503572
- 3008868758
- 8010177
- 3007113169
- 3013846070
- 3003541440
- 3013561205
- 3010120104
- 3016727307
- 3010120148
- 3022777867
- 3015882686
- 3014315669
- 3012478585
- 3016050940
- 3019807891
- 3011061237
- 3015453963
- 3010047402
- 1051526
- 1220477
- 1835444
- 3010039400
- 2183967
- 3011053036
- 3014644608
- 3021948057
- 9680825
- 3012447612
- 3009513193
- 3004549189
- 3007334927
- 3016778139
- 1828288
- 8043971
- 3009201148
- 2648666
- 3029894043
- 3015869121
- 3005977257
- 3010197224
- 1450662
- 3025114181
- 3017980495
- 3016237080
- 3027827832
- 1226425
- 3009144915
- 2030624
- 3002808145
- 3011301313
- 3011989923
- 3010531069
- 9610612
- 3034676720
- 3019767615
- 3009394448
- 3010047454
- 3017191784
Source Documents#
Other 510(k) Records For Product Code HWC #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261057 | ActivaScrew™ Cannulated COM | Bioretec, Ltd. | 2026-09-04 |
| K260106 | OsteoCoil™ GT Active Compression System | Flower Orthopedics Corporation DBA Conventus Flower Orthoped | 2026-08-24 |
| K262344 | Large Compression Screws | TriMed, Inc. | 2026-08-12 |
| K253858 | GFS - Sterile Screws and Top Hat | T.A.G. Medical Products Corporation, Ltd. | 2026-08-05 |
| K262075 | Lapidus Screw Kit | Relja Innovations, LLC | 2026-07-22 |
| K260809 | Arthrex Sterile VAL and VAL KreuLock™ Compression Screw System | Arthrex, Inc. | 2026-06-25 |
| K253108 | VEOFIX Snap Off Screw | Steps Ortho | 2026-06-05 |
| K261154 | CoLink® & CoLag® Non-Sterile Screws | In2Bones USA, LLC | 2026-05-30 |
| K261241 | TriMed Compression Screws | TriMed, Inc. | 2026-05-14 |
| K254215 | Arthrex Beaming System | Arthrex, Inc. | 2026-05-08 |
| K254077 | OSSIOfiber® Threaded Trimmable Fixation Nail | OSSIO , Ltd. | 2026-05-01 |
| K260934 | TITAN Nail; APTUS K-Wire System | Medartis AG | 2026-04-17 |
| K252699 | CoAptix S System | University of Utah, Department of Orthopaedics | 2026-04-10 |
| K253042 | Tyber Medical Trauma Screw | Tyber Medical, LLC | 2026-04-03 |
| K254110 | DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip Delta; DynaClip Quattro | MedShape, Inc. | 2026-03-18 |
Legacy Summary#
summary
FDA Review#
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