PROXIMAL HUMERUS SCAFFOLD FIXATION SYSTEM (PHSFS)

Plate, Fixation, Bone

TOBY ORTHOPAEDICS, LLC

The following data is part of a premarket notification filed by Toby Orthopaedics, Llc with the FDA for Proximal Humerus Scaffold Fixation System (phsfs).

Pre-market Notification Details

• Device ID: K081608
• 510k Number: K081608
• Device Name: PROXIMAL HUMERUS SCAFFOLD FIXATION SYSTEM (PHSFS)
• Classification: Plate, Fixation, Bone
• Applicant: TOBY ORTHOPAEDICS, LLC 3773 MATHESON AVENUE Miami, FL 33133
• Contact: Al Weisenborn
• Correspondent: Al Weisenborn; TOBY ORTHOPAEDICS, LLC 3773 MATHESON AVENUE Miami, FL 33133
• Product Code: HRS
• CFR Regulation Number: 888.3030 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2008-06-09
• Decision Date: 2008-12-19
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00816101017546	K081608	000
00816101017416	K081608	000
00816101017409	K081608	000
00816101017393	K081608	000
00816101017386	K081608	000
00816101017379	K081608	000
00816101017362	K081608	000
00816101017355	K081608	000
00816101017348	K081608	000
00816101017331	K081608	000
00816101017850	K081608	000
00816101017423	K081608	000
00816101017430	K081608	000
00816101017539	K081608	000
00816101017522	K081608	000
00816101017515	K081608	000
00816101017508	K081608	000
00816101017492	K081608	000
00816101017485	K081608	000
00816101017478	K081608	000
00816101017461	K081608	000
00816101017454	K081608	000
00816101017447	K081608	000
00816101017843	K081608	000
00816101017836	K081608	000
00816101017706	K081608	000
00816101017690	K081608	000
00816101017683	K081608	000
00816101017676	K081608	000
00816101017669	K081608	000
00816101017652	K081608	000
00816101017645	K081608	000
00816101017638	K081608	000
00816101017621	K081608	000
00816101017614	K081608	000
00816101017713	K081608	000
00816101017720	K081608	000
00816101017829	K081608	000
00816101017812	K081608	000
00816101017805	K081608	000
00816101017799	K081608	000
00816101017782	K081608	000
00816101017775	K081608	000
00816101017768	K081608	000
00816101017751	K081608	000
00816101017744	K081608	000
00816101017737	K081608	000
00816101017607	K081608	000
00816101010172	K081608	000
00816101010196	K081608	000
00816101010189	K081608	000
00816101010158	K081608	000
00816101010141	K081608	000
00816101010134	K081608	000
00816101010127	K081608	000
00816101010110	K081608	000
00816101010103	K081608	000
00816101010097	K081608	000
00816101010080	K081608	000
00816101010202	K081608	000
00816101010219	K081608	000
00816101017324	K081608	000
00816101017317	K081608	000
00816101017300	K081608	000
00816101017294	K081608	000
00816101017287	K081608	000
00816101010493	K081608	000
00816101010486	K081608	000
00816101010479	K081608	000
00816101010233	K081608	000
00816101010226	K081608	000
00816101010073	K081608	000
00816101010066	K081608	000
00816101010943	K081608	000
00816101010288	K081608	000
00816101010271	K081608	000
00816101010264	K081608	000
00816101010257	K081608	000
00816101017966	K081608	000
00816101017591	K081608	000
00816101017584	K081608	000
00816101017577	K081608	000
00816101017560	K081608	000
00816101010950	K081608	000
00816101010998	K081608	000
00816101010059	K081608	000
00816101010042	K081608	000
00816101010035	K081608	000
00816101010028	K081608	000
00816101010011	K081608	000
00816101013548	K081608	000
00816101013531	K081608	000
00816101011025	K081608	000
00816101011018	K081608	000
00816101011001	K081608	000
00816101017553	K081608	000