510(k) K230527

Device: WishBone Medical Plate and Screw System
Applicant: Wishbone Medical, Inc.
510(k) number: K230527
Product code: HRS
Decision: Substantially Equivalent (SESE)
Decision date: 2023-03-29
Date received: 2023-02-27
Regulation: 888.3030
Classification name: Plate, Fixation, Bone
Medical specialty: Orthopedic
Review panel: Orthopedic
Device class: 2
Clearance type: Special
Statement or summary: Summary
Third party reviewed: No

Related Records

Applicant Contact

Contact: Kayla Johnston
Address: 100 Capital Dr. Warsaw IN US 46582 46582

FDA Registration Numbers

3014273424
2029447
3010673777
3006981798
3014763043
3013756169
3013194153
3016655171
3011354099
9610622
3013700547
3010287737
2320767
3010400367
3010047454
3032588003
9613910
1421101
3038503572
1043653
3009540749
3008868758
2028632
2245304
2183967
9611278
3026035863
3010097171
3011301313
3017980266
3009756327
1032347
3000170817
1220477
3011530718
3009888740
3003761012
3010047402
9611274
3015410662
8031010
3017528621
3016261131
3006272282
3009417901
3021010222
3011580264
3017191784
3015831087
3011230048
1822565
3010536692
9710312
3002993234
3013413393
3008572101
3004187715
3006694268
1527105
3005751028
1835831
1935627
2134285
1828464
3004513872
3002807310
3006801265
1834331
3011388423
1054811
3009941480
3018077525
1030489
1424263
3019807891
3008102042
3015531529
3008236846
3012818475

Source Documents

510(k) summary PDF

Related GUDID Devices

Primary DI	Brand	Company	Published
B56211113940006S10	PRIMA Proximal Femur Locking Plate System	Wishbone Medical, Inc.	2023-04-12
B56211113040014S10	PRIMA Proximal Femur Locking Plate System	Wishbone Medical, Inc.	2023-04-12
B562PKPF450000	PRIMA Proximal Femur Locking Plate System	Wishbone Medical, Inc.	2023-04-12
B56211113030006S10	PRIMA Proximal Femur Locking Plate System	Wishbone Medical, Inc.	2023-04-12
B56211113030012S10	PRIMA Proximal Femur Locking Plate System	Wishbone Medical, Inc.	2023-04-12
B56211113140006S10	PRIMA Proximal Femur Locking Plate System	Wishbone Medical, Inc.	2023-04-12
B56211113130006S10	PRIMA Proximal Femur Locking Plate System	Wishbone Medical, Inc.	2023-04-12
B56211113301800S10	PRIMA Proximal Femur Locking Plate System	Wishbone Medical, Inc.	2023-04-12
B562PKPF350000	PRIMA Proximal Femur Locking Plate System	Wishbone Medical, Inc.	2023-04-12
B56211113431800S10	PRIMA Proximal Femur Locking Plate System	Wishbone Medical, Inc.	2023-04-12
B56211113361800S10	PRIMA Proximal Femur Locking Plate System	Wishbone Medical, Inc.	2023-04-12
B56211113441800S10	PRIMA Proximal Femur Locking Plate System	Wishbone Medical, Inc.	2023-04-12
B56211113930006S10	PRIMA Proximal Femur Locking Plate System	Wishbone Medical, Inc.	2023-04-12
B56211114301800S10	PRIMA Proximal Femur Locking Plate System	Wishbone Medical, Inc.	2023-04-12
B56211113381800S10	PRIMA Proximal Femur Locking Plate System	Wishbone Medical, Inc.	2023-04-12
B56211113341800S10	PRIMA Proximal Femur Locking Plate System	Wishbone Medical, Inc.	2023-04-12
B56211113940014S10	PRIMA Proximal Femur Locking Plate System	Wishbone Medical, Inc.	2023-04-12
B56211113331800S10	PRIMA Proximal Femur Locking Plate System	Wishbone Medical, Inc.	2023-04-12
B56211113140014S10	PRIMA Proximal Femur Locking Plate System	Wishbone Medical, Inc.	2023-04-12
B56211113331800S01	PRIMA Proximal Femur Locking Plate System	Wishbone Medical, Inc.	2023-04-12
B56211114930006S10	PRIMA Proximal Femur Locking Plate System	Wishbone Medical, Inc.	2023-04-12
B56211113930012S10	PRIMA Proximal Femur Locking Plate System	Wishbone Medical, Inc.	2023-04-12
B56211113130012S10	PRIMA Proximal Femur Locking Plate System	Wishbone Medical, Inc.	2023-04-12
B56211114381800S10	PRIMA Proximal Femur Locking Plate System	Wishbone Medical, Inc.	2023-04-12
B56211113040006S10	PRIMA Proximal Femur Locking Plate System	Wishbone Medical, Inc.	2023-04-12
B56211114361800S10	PRIMA Proximal Femur Locking Plate System	Wishbone Medical, Inc.	2023-04-12
B56211113930014S10	PRIMA Proximal Femur Locking Plate System	Wishbone Medical, Inc.	2023-04-12
B56211114341800S010	PRIMA Proximal Femur Locking Plate System	Wishbone Medical, Inc.	2023-04-12
B56211902035065S10	PRIMA Femoral Locking Plate System	Wishbone Medical, Inc.	2023-04-11
B56211902035060S10	PRIMA Femoral Locking Plate System	Wishbone Medical, Inc.	2023-04-11

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